(74 days)
The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.
The current Micros Spherical MicroCoil System (510k # K002056) is available in 10 and 18 system sizes.
The 10 System Spherical MicroCoils are available in diameters ranging from 2 mm to 10 mm and in lengths ranging from 2 cm to 20 cm.
The 18 System Spherical MicroCoils are available in diameters ranging from 2 mm to 19 mm and in lengths ranging from 2 cm to 30 cm.
The proposed longer Spherical MicroCoil, which is the focus of this submission, is designed to provide move aneurysm-framing loops to provide better aneurysm wall and aneurysm neck coverage in aneurysms ranging from 6 to 10 mm in size:
The "Long 10 System Spherical" MicroCoils will be available in diameters ranging from 6 mm to 10 mm and in lengths ranging from 20 cm to 30 cm.
These long Spherical MicroCoils are a line extension of the current regular length Micrus Spherical MicroCoils.
Both the original length and long length Spherical MicroCoil Systems are "framing" coils, to be used interchangeably to frame the inner wall of the aneurysm prior to filling it with Helical MicroCoils. All Micrus MicroCoils are part of the complete Micrus MicroCoil Delivery System, which has three components (sold and provided individually):
- Micrus Platinum MicroCoil Systems, Spherical, Straight, and Stretch Resistant configurations, consist of an embolic coil attached to a variable stiffness Device Positioning Unit (DPU). The DPU has a radiopaque marker band located three (3) centimeters from its distal end for compatibility with infusion microcatheters with 2 tip markers.
- Detachment Control Boxes (DCB). This device provides the energy to detach the MicroCoil from the DPU at the clinician's command. The DCB is provided NON-STERILE.
- Connecting Cable. The Connecting Cable is used to bring the energy from the DCB to the MicroCoil System, and is approximately 5-ft (1.5 m) long.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to address your specific questions:
Acceptance Criteria and Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| V0381: Durability | Withstand 6 cycles of deployment and retraction through the tip of the microcatheter in a tortuous anatomy flow model without stretching, knotting, or breaking. | The 10 System long Spherical MicroCoil System demonstrates the durability to withstand 6 cycles of deployment and retraction through the tip of the microcatheter in a tortuous anatomy flow model without stretching, knotting, or breaking. |
| V0384: Advancement, Retraction, and Framing | Able to advance, retract, frame the aneurysm, and enable packing of the framed aneurysm with helical filler coils. | The long Spherical MicroCoil System is able to advance, retract, frame the aneurysm, and enable packing of the framed aneurysm with helical filler coils. |
| V0387: Frictional Forces | Frictional forces equal to or less than the currently marketed helically shaped and spherically shaped MicroCoil systems. | The frictional forces of the long Spherical MicroCoil System were equal or less than the currently marketed helically shaped and spherically shaped MicroCoil systems. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes non-clinical tests. There is no mention of a human test set, clinical data, or data provenance (country of origin, retrospective/prospective). The tests referenced are in vitro (flow model and frictional force testing).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The tests are non-clinical, mechanical/performance evaluations. Ground truth for clinical data is not mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as there is no human test set or clinical data requiring adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device for embolization, not an AI diagnostic tool. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these non-clinical tests would be the pre-defined performance specifications (refer to "Acceptance Criteria" table above) for mechanical properties and functional performance (durability, ability to advance/retract/frame, and frictional forces). These are engineering specifications rather than clinical ground truth like pathology or expert consensus.
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The sample size for the training set
- Not applicable. This is not an AI/machine learning device; therefore, there is no training set.
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How the ground truth for the training set was established
- Not applicable for the same reason as above.
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II. Safety and Effectiveness Summary
Contact Information A.
Margaret Webber Director, Regulatory & Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085 Tel: 408-830-5900, ext. 108 Fax: 408-830-5910
B. Device Name
Long Spherical MicroCoil System (member of MicroCoil Delivery System)
Device, Artificial Embolization
Regulation Number: 882.5950
Product Code: HCG
Device Class: Ill
C. Predicate Device
510k# K002056: Micrus MicroCoil Delivery System, cleared on Jan 11, 2001.
Device Description D.
The current Micros Spherical MicroCoil System (510k # K002056) is available in 10 and 18 system sizes.
- The 10 System Spherical MicroCoils are available in diameters ranging from 2 mm to 10 mm and in lengths ranging from 2 cm to 20 cm.
- . The 18 System Spherical MicroCoils are available in diameters ranging from 2 mm to 19 mm and in lengths ranging from 2 cm to 30 cm.
The proposed longer Spherical MicroCoil, which is the focus of this submission, is designed to provide move aneurysm-framing loops to provide better aneurysm wall and aneurysm neck coverage in aneurysms ranging from 6 to 10 mm in size:
- 트 The "Long 10 System Spherical" MicroCoils will be available in diameters ranging from 6 mm to 10 mm and in lengths ranging from 20 cm to 30 cm.
These long Spherical MicroCoils are a line extension of the current regular length Micrus Spherical MicroCoils. The table below shows the lengths of both the regular and proposed long Spherical MicroCoils.
Comparison Table: Long Spherical MicroCoils Vs. Current Spherical MicroCoils
| Long SphericalMicroCoil Sizes | Current SphericalMicroCoil Sizes |
|---|---|
| 6 mm x 20 cm | 6 mm x 12cm |
| 7 mm x 20 cm | 7 mm x 14cm |
| 8 mm x 25 cm | 8 mm x 16 cm |
| 9 mm x 25 cm | 9 mm x 18.5 cm |
| 10 mm x 30 cm | 10 mm x 20.5 cm |
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Both the original length and long length Spherical MicroCoil Systems are "framing" coils, to be used interchangeably to frame the inner wall of the aneurysm prior to filling it with Helical MicroCoils. All Micrus MicroCoils are part of the complete Micrus MicroCoil Delivery System, which has three components (sold and provided individually):
- Micrus Platinum MicroCoil Systems, Spherical, Straight, and Stretch 1) Resistant configurations, consist of an embolic coil attached to a variable stiffness Device Positioning Unit (DPU). The DPU has a radiopaque marker band located three (3) centimeters from its distal end for compatibility with infusion microcatheters with 2 tip markers.
-
- Detachment Control Boxes (DCB). This device provides the energy to detach the MicroCoil from the DPU at the clinician's command. The DCB is provided NON-STERILE.
-
- Connecting Cable. The Connecting Cable is used to bring the energy from the DCB to the MicroCoil System, and is approximately 5-ft (1.5 m) long.
Note: The MicroCoil System and the Connecting Cable are provided sterile and nonpyrogenic, if in their unopened packages.
E. Intended Use
The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.
Intended Use (Predicate) F.
The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.
| Characteristic | Micrus Current SphericalMicroCoil (10-System) | Proposed Longer SphericalMicroCoil (10-System) | Comparison |
|---|---|---|---|
| MicroCoil System | |||
| How supplied | Sterile, single use. MicroCoilattached to the DPU, polyethyleneintroducer over MicroCoil, in plasticpackaging hoop. | Sterile, single use. Embolic coilattached to the pusher wire,polyethylene introducer overembolic coil, in plastic packaginghoop. | Identical |
| ImplantableEmbolic Coil | |||
| Materials ofconstruction | Platinum/Tungsten alloy wire &Au/Sn solder. | Platinum/Tungsten alloy wire &Au/Sn solder. | Identical |
| Shape | 3D Spherical shape with atraumatictip. | 3D Spherical shape with atraumatictip. | Identical |
| Dimensions | Various diameters and lengths totreat a variety of aneurysm sizes.Diameters from 2 - 12 mmLengths from 2.5 cm to 20.5 cm. | Various diameters and lengths totreat a variety of aneurysm sizes.Diameters from 6 -10 mmLengths from 20 - 30 cm | Within samediameter range.Longer lengthsavailable. |
| Radiopacity | Radiopaque from Pt alloy wire. | Radiopaque from Pt alloy wire. | Identical |
| MRI Compatibility | Yes | Yes | Identical |
| Method ofattachment todevice positioningunit | High tensile strength, highly orientedpolyethylene fiber. | High tensile strength, highly orientedpolyethylene fiber. | Identical |
| Method ofdetachment fromdevice positioningunit | Shear PE fiber with a loop of aresistively heated coil. | Shear PE fiber with a loop of aresistively heated coil. | Identical |
| Provided: | Sterile, single use | Sterile, single use | Identical |
| Characteristic | Micrus Current SphericalMicroCoil (10-System) | Proposed Longer SphericalMicroCoil (10-System) | Comparison |
| DevicePositioning Unit | |||
| Physical | Variable stiffness compositeintroducer (most flexible distally,medium flexibility in mid-section andstiffest proximally) to allow pushingof the embolic coil through thetortuous cerebral vasculature. | Variable stiffness compositeintroducer (most flexible distally,medium flexibility in mid-section andstiffest proximally) to allow pushingof the embolic coil through thetortuous cerebral vasculature. | Identical |
| Construction | Stainless steel hypotube (proximal),stainless steel braid (mid) andpolymer (distal) sheathing for 2conduction wires and distal RH coil. | Stainless steel hypotube (proximal),stainless steel braid (mid) andpolymer (distal) sheathing for 2conduction wires and distal RH coil. | Identical |
| Working Length | 195 cm | 195 cm | Identical |
| PackageConfiguration | In plastic packaging hoop, withintroducer in place (for introductionof MicroCoil into the microcatheter) | In plastic packaging hoop, withintroducer in place (for introductionof coil into the microcatheter) | Identical |
| Compatible with: | Microcatheters with minimum 0.14"i.d. ("10" sized systems) with 2radiopaque tip markers 3 cm apart(examples: Tracker 10, Excel 14,Prowler 10, Prowler 14) | Microcatheters with minimum 0.14"i.d. ("10" sized systems) with 2radiopaque tip markers 3 cm apart(examples: Tracker 10, Excel 14,Prowler 10, Prowler 14) | Identical |
| ConnectingCables | |||
| How supplied | Sterile, single use | Sterile, single use | Identical |
| Physical | Single cable with proprietaryconnectors to fit only the Micrus DCBand the Micrus MicroCoil System | Single cable with proprietaryconnectors to fit only the MicrusDCB and the Micrus MicroCoilSystem | Identical |
| Length | 262 cm. | 262 cm. | Identical |
| Detachment Box | |||
| How supplied | Non-Sterile, reusable. Used outsidethe sterile field. | Non-Sterile, reusable. Used outsidethe sterile field. | Identical |
| Power Source | Alkaline batteries. | Alkaline batteries. | Identical |
| Displays | Voltage, Current, Low Battery, Fault,Detach Cycle | Voltage, Current, Low Battery, Fault,Detach Cycle | Identical |
| Detachment CycleDuration | 5 seconds | 5 seconds | Identical |
| Output Voltage | 6.5 VDC | 6.5 VDC | Identical |
| Output Current | 125 mA nominal, 200 mA max. | 125 mA nominal, 200 mA max. | Identical |
| "Detach" feedback | "Detach Cycle" light goes fromilluminated to off. Clinician verifiesdetachment fluoroscopically perdevice labeling. | "Detach Cycle" light goes fromilluminated to off. Clinician verifiesdetachment fluoroscopically perdevice labeling. | Identical |
| Method of attachingConnecting Cableto Detachment Box | Proprietary connector fits only oneway to assure proper polarity. | Proprietary connector fits only oneway to assure proper polarity. | Identical |
| Flow of Current | From positive terminal, throughpositive lead in connecting cable,through positive conductor of DPU,through resistance heating coil,through negative conductor of DPU,through negative lead in connectingcable, back to negative terminal ofdetachment control box. | From positive terminal, throughpositive lead in connecting cable,through positive conductor of DPU,through resistance heating coil,through negative conductor of DPU,through negative lead in connectingcable, back to negative terminal ofdetachment control box. | Identical |
| Characteristic | Micrus Current Spherical MicroCoil (10-System) | Proposed Longer Spherical MicroCoil (10-System) | Comparison |
| AccessoryProducts Requiredto Perform theProcedure. | Micrus Sterile Connecting Cable | Micrus Sterile Connecting Cable | Identical |
| Micrus Detachment Control Box5-7F Guide Catheter*Microcatheter (see above)Guide wire compatible with microcatheterContinuous saline/heparin saline flush*Rotating hemostatic valves*3-Way stopcock*1-Way valve*IV pole*Femoral Sheath*Alkaline Batteries* | Micrus Detachment Control Box5-7F Guide Catheter*Microcatheter (see above)Guide wire compatible with microcatheterContinuous saline/heparin saline flush*Rotating hemostatic valves*3-Way stopcock*1-Way valve*IV pole*Femoral Sheath*Alkaline Batteries* | ||
| * - Not provided aspart of the system,chosen based uponphysicianexperience andpreference. |
Technological Comparison G.
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KO32872
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This technological comparison demonstrates the substantially equivalent technologies used in the proposed longer MicroCoil System and the predicate Micrus MicroCoil System.
Discussion of Non-Clinical Tests and Conclusions H.
The non-clinical tests performed on the Micrus longer Spherical MicroCoil System were based upon the intended use of the device and the performance of the predicate Micrus regular length Spherical MicroCoil System.
The following table outlines the important device characteristics and the non-clinical test data generated:
| Test | Proposed Long Spherical MicroCoil System | SubstantialEquivalence to thecurrent MicrusSpherical MicroCoilSystem |
|---|---|---|
| V0381 | The 10 System long Spherical MicroCoilSystem demonstrates the durability towithstand 6 cycles of deployment andretraction through the tip of the microcatheterin a tortuous anatomy flow model withoutstretching, knotting, or breaking. | Substantiallyequivalent |
| V0384 | The long Spherical MicroCoil System is able toadvance, retract, frame the aneurysm, andenable packing of the framed aneurysm withhelical filler coils. | Substantiallyequivalent |
| V0387 | The frictional forces of the long SphericalMicroCoil System were equal or less than thecurrently marketed helically shaped andspherically shaped MicroCoil systems. | Substantiallyequivalent |
This non-clinical testing has demonstrated the substantially equivalent performance of the Micrus Long Spherical MicroCoil System with the predicate Micrus Regular Length Spherical MicroCoil System.
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NOV 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, California 94085
Re: K032872
Trade/Device Name: MicroCoil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: September 11, 2003 Received: September 15, 2003
Dear Ms. Webber:
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 preval application (PM) ). You may, therefore, market the device, subject to the general controls provisions of the Act. Hhe general controls provisions of the Act include requirements for annual registration. Insting 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark N Millerm
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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Device Name:
510(k) Number (if known):
Indications for Use:
The MicroCoil System is intended for endovascular embolization of intracranial aneurysms.
(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)
fo Mark N. Millerson
JIVISION Sign-Ciff) Division of Cercral, Restorative and Neurological Devices
Number K032872
§ 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).