(74 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the microcoils and delivery system, with no mention of AI or ML.
Yes
The device is intended for endovascular embolization of intracranial aneurysms, which is a therapeutic intervention to treat a medical condition.
No
The device is intended for endovascular embolization of intracranial aneurysms, which is a treatment procedure, not a diagnostic one.
No
The device description clearly outlines physical components including platinum microcoils, a Device Positioning Unit (DPU), Detachment Control Boxes (DCB), and a Connecting Cable. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endovascular embolization of intracranial aneurysms." This describes a therapeutic procedure performed within the patient's body to treat a medical condition.
- Device Description: The description details a physical device (microcoils, delivery unit, control box, cable) used to physically block blood flow in an aneurysm.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (in glass, or outside the body) to diagnose diseases or other conditions. This device is clearly intended for in vivo (within the body) therapeutic use.
N/A
Intended Use / Indications for Use
The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
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.
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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial aneurysms.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- V0381: 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. (Substantially equivalent)
- V0384: The long Spherical MicroCoil System is able to advance, retract, frame the aneurysm, and enable packing of the framed aneurysm with helical filler coils. (Substantially equivalent)
- V0387: The frictional forces of the long Spherical MicroCoil System were equal or less than the currently marketed helically shaped and spherically shaped MicroCoil systems. (Substantially equivalent)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
510k# K002056
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
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 Spherical
MicroCoil Sizes | Current Spherical
MicroCoil 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 |
1
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 Spherical
MicroCoil (10-System) | Proposed Longer Spherical
MicroCoil (10-System) | Comparison |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| MicroCoil System | | | |
| How supplied | Sterile, single use. MicroCoil
attached to the DPU, polyethylene
introducer over MicroCoil, in plastic
packaging hoop. | Sterile, single use. Embolic coil
attached to the pusher wire,
polyethylene introducer over
embolic coil, in plastic packaging
hoop. | Identical |
| Implantable
Embolic Coil | | | |
| Materials of
construction | Platinum/Tungsten alloy wire &
Au/Sn solder. | Platinum/Tungsten alloy wire &
Au/Sn solder. | Identical |
| Shape | 3D Spherical shape with atraumatic
tip. | 3D Spherical shape with atraumatic
tip. | Identical |
| Dimensions | Various diameters and lengths to
treat a variety of aneurysm sizes.
Diameters from 2 - 12 mm
Lengths from 2.5 cm to 20.5 cm. | Various diameters and lengths to
treat a variety of aneurysm sizes.
Diameters from 6 -10 mm
Lengths from 20 - 30 cm | Within same
diameter range.
Longer lengths
available. |
| Radiopacity | Radiopaque from Pt alloy wire. | Radiopaque from Pt alloy wire. | Identical |
| MRI Compatibility | Yes | Yes | Identical |
| Method of
attachment to
device positioning
unit | High tensile strength, highly oriented
polyethylene fiber. | High tensile strength, highly oriented
polyethylene fiber. | Identical |
| Method of
detachment from
device positioning
unit | Shear PE fiber with a loop of a
resistively heated coil. | Shear PE fiber with a loop of a
resistively heated coil. | Identical |
| Provided: | Sterile, single use | Sterile, single use | Identical |
| Characteristic | Micrus Current Spherical
MicroCoil (10-System) | Proposed Longer Spherical
MicroCoil (10-System) | Comparison |
| Device
Positioning Unit | | | |
| 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 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. | Identical |
| Construction | Stainless steel hypotube (proximal),
stainless steel braid (mid) and
polymer (distal) sheathing for 2
conduction wires and distal RH coil. | Stainless steel hypotube (proximal),
stainless steel braid (mid) and
polymer (distal) sheathing for 2
conduction wires and distal RH coil. | Identical |
| Working Length | 195 cm | 195 cm | Identical |
| Package
Configuration | In plastic packaging hoop, with
introducer in place (for introduction
of MicroCoil into the microcatheter) | In plastic packaging hoop, with
introducer in place (for introduction
of coil into the microcatheter) | Identical |
| Compatible with: | Microcatheters with minimum 0.14"
i.d. ("10" sized systems) with 2
radiopaque 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 2
radiopaque tip markers 3 cm apart
(examples: Tracker 10, Excel 14,
Prowler 10, Prowler 14) | Identical |
| Connecting
Cables | | | |
| How supplied | Sterile, single use | Sterile, single use | Identical |
| Physical | Single cable with proprietary
connectors to fit only the Micrus DCB
and the Micrus MicroCoil System | Single cable with proprietary
connectors to fit only the Micrus
DCB and the Micrus MicroCoil
System | Identical |
| Length | 262 cm. | 262 cm. | Identical |
| Detachment Box | | | |
| How supplied | Non-Sterile, reusable. Used outside
the sterile field. | Non-Sterile, reusable. Used outside
the 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 Cycle
Duration | 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 from
illuminated to off. Clinician verifies
detachment fluoroscopically per
device labeling. | "Detach Cycle" light goes from
illuminated to off. Clinician verifies
detachment fluoroscopically per
device labeling. | Identical |
| Method of attaching
Connecting Cable
to Detachment Box | Proprietary connector fits only one
way to assure proper polarity. | Proprietary connector fits only one
way to assure proper polarity. | Identical |
| 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 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. | Identical |
| Characteristic | Micrus Current Spherical MicroCoil (10-System) | Proposed Longer Spherical MicroCoil (10-System) | Comparison |
| Accessory
Products Required
to Perform the
Procedure. | Micrus Sterile Connecting Cable | Micrus Sterile Connecting Cable | Identical |
| | Micrus Detachment Control Box
5-7F Guide Catheter*
Microcatheter (see above)*
Guide wire compatible with microcatheter*
Continuous saline/heparin saline flush*
Rotating hemostatic valves*
3-Way stopcock*
1-Way valve*
IV pole*
Femoral Sheath*
Alkaline Batteries* | Micrus Detachment Control Box
5-7F Guide Catheter*
Microcatheter (see above)*
Guide wire compatible with microcatheter*
Continuous saline/heparin saline flush*
Rotating hemostatic valves*
3-Way stopcock*
1-Way valve*
IV pole*
Femoral Sheath*
Alkaline Batteries* | |
| * - Not provided as
part of the system,
chosen based upon
physician
experience and
preference. | | | |
Technological Comparison G.
2
page 3 of 4
KO32872
3
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 | Substantial
Equivalence to the
current Micrus
Spherical MicroCoil
System |
|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| V0381 | 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. | Substantially
equivalent |
| V0384 | The long Spherical MicroCoil System is able to
advance, retract, frame the aneurysm, and
enable packing of the framed aneurysm with
helical filler coils. | Substantially
equivalent |
| V0387 | The frictional forces of the long Spherical
MicroCoil System were equal or less than the
currently marketed helically shaped and
spherically shaped MicroCoil systems. | Substantially
equivalent |
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.
4
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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.
5
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
6
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