(57 days)
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus Modified MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Micros Modified MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are available in helical and spherical shapes and are available in various diameters/lengths: Coil lengths range from 1 to 30 centimeters. Coil diameters range from 2 to 10 millimeters. Micrus Modified MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The difference between the Micros Modified MicroColl and the Micros Stretch Resistant MicroCoil is that the Modified MicroCoil and the MicroCoil contains absorbable polyglycolic acid (PGA) suture whereas the Stretch Resistant MicroCoil contains non-absorbable polypropylene suture. The Modified MicroCoils are available in both stretch resistant and non-stretch resistant configurations with different stiffness characteristics and stretch resistant properties.
Here's a summary of the acceptance criteria and study information for the Micrus Modified MicroCoil System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Acute Animal Testing (V0327-acute outcome) | Aneurysm occlusion and detachment reliability similar to predicate devices. | Coils detached with the first detachment cycle in > 95% of detachments and ≥90% aneurysm occlusion was obtained in all 5 aneurysms. |
| Chronic Animal Testing for Coil Stability & Aneurysm Occlusion (V0327-chronic outcome) | Positional stability and aneurysm occlusion maintained through extended implant duration; no coil compaction. | Positional stability and aneurysm occlusion maintained through 6 months of implant. No coil compaction present at 6-month angio. Histology showed chronic biocompatibility per study V0401. |
| Coil Stiffness/Softness for Wide Pitch Modified MicroCoils (V0396) | Stiffness limits for loosely wound (wide pitch) modified coils must be met. | The loosely wound (wide pitch) Helical and Spherical Modified MicroCoils met the stiffness specifications. |
| Friction in the Microcatheter (Delivery Force) (V0429) | Average push force must be substantially equivalent to predicate devices. | The Modified MicroCoil had average push forces that are comparable to those of the predicate. |
| Biocompatibility of Materials (V0401 & V0435) | Meets the requirements of ISO 10993 for new materials. | The only new material in the Micrus Modified MicroCoil is absorbable suture, which passed ISO 10993 biocompatibility testing. |
| Sterilization Validation (V0394) | Minimum Sterility Assurance Level of 10-6. | Passed minimum sterility assurance level of 10-6. |
| Shelf Life Test (V0397) | No performance degradation after 3 years of shelf life aging. | Minimum tensile strength after 3 year accelerated aging shows no degradation. |
| Tensile Strength: Stretch Resistant Modified MicroCoils (V0427) | Pre-detachment tensile strength of the suture ball tip and MicroCoil to DPU must be substantially equivalent to the stretch resistant predicate. | Tensile strength meets desired strength criteria. |
| Tensile Strength: Non-Stretch Resistant Modified MicroCoils (V0398) | Pre-detachment tensile strength of the MicroCoil to DPU must be substantially equivalent to the non-stretch resistant predicate. | Tensile strength meets desired strength criteria. |
| Tensile Strength: Non-Stretch Resistant (suture ball tip) (V0428) | Pre-detachment tensile strength of the suture ball tip and MicroCoil must be substantially equivalent to the non-stretch resistant predicate. | Tensile strength meets desired strength criteria. |
| Durability (Reliability after Fatigue) (V0405) | Withstand deployment and retraction 6 times in a tortuous anatomy without knotting, breakage, or stretching. | No knotting, no breakage, no stretching occurred. Durability meets desired durability criteria. |
| MRI Compatibility of Implant | No change in MRI compatibility compared to predicate. | No change was made which would impact MRI compatibility (Therefore, it is assumed to be substantially equivalent to the predicates which are MRI compatible). |
| Package Integrity (V0399) | Demonstrate package integrity per ISO 11607. | Meets ISO 11607 criteria. |
| Ship/Transit (V0400) | Successfully withstand domestic and international distribution environment. | Does successfully withstand domestic and international distribution environment. |
2. Sample Size Used for the Test Set and Data Provenance:
- Acute Animal Testing: 5 aneurysms were tested. The study did not specify the type of animal used, but "animal testing" implies a prospective animal study. The country of origin is not specified.
- Chronic Animal Testing: Covers 6 months of implant. The study did not specify the type of animal used, but "animal testing" implies a prospective animal study. The country of origin is not specified.
- Other tests (Coil Stiffness, Friction, Biocompatibility, Sterilization, Shelf Life, Tensile Strength, Durability, Package Integrity, Ship/Transit): The specific sample sizes for these bench and materials tests are not explicitly stated in the provided text. The data provenance is laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This document describes pre-market device testing (bench, animal) for substantial equivalence to predicate devices, not studies involving human image analysis or diagnostic performance. Therefore, there is no mention of experts establishing ground truth in the context of image analysis or clinical diagnosis. The "ground truth" for these tests relates to physical measurements and biological responses defined by established scientific and engineering principles.
4. Adjudication Method for the Test Set:
- As explained above, this document does not describe studies requiring expert adjudication of a test set in the typical sense (e.g., medical image interpretation). The evaluation of results from the non-clinical tests would have been based on pre-defined criteria and measurements.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This device is an implantable medical device (microcoil), and the studies described are non-clinical (bench and animal) tests to demonstrate safety and effectiveness for a 510(k) submission, not comparative effectiveness studies of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. The device is a physical medical implant, not an AI algorithm. The performance described is the standalone performance of the physical device in laboratory and animal models.
7. The Type of Ground Truth Used:
- The ground truth varied depending on the test:
- Acute/Chronic Animal Testing: Pathological findings, angiographic results (aneurysm occlusion), and observation of device stability and detachment success.
- Biocompatibility: Conformance to ISO 10993 standards.
- Mechanical Tests (Stiffness, Friction, Tensile Strength, Durability): Quantitative physical measurements against established engineering specifications and comparison to predicate device performance.
- Sterilization, Shelf Life, Package Integrity, Ship/Transit: Conformance to relevant ISO standards and industry best practices.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See #8).
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055813
page 1 . 4 14
Safety and Effectiveness Summary ll.
A. Contact Information
Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085 Tel:
408-830-5900, ext. 108 Fax: 408-830-5910
B. Device Name
Micrus Modified MicroCoil System, "Cerecyte"
Device, Artificial Embolization
Regulation Number: 882.5950
Product Code: HCG
Device Class: !!!
C. Predicate Device(s)
| Number | Description | ClearanceDate |
|---|---|---|
| K022420 | Micrus Stretch Resistant MicroCoil System | 10/22/02 |
| K002056 | Micrus MicroCoil Delivery System | 01/11/01 |
D. Device Description
The Micrus Modified MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile).
The Micros Modified MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are available in helical and spherical shapes and are available in various diameters/lengths:
- Coil lengths range from 1 to 30 centimeters. .
- Coil diameters range from 2 to 10 millimeters.
Micrus Modified MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The difference between the Micros Modified MicroColl and the Micros Stretch Resistant MicroCoil is that the Modified MicroCoil and the MicroCoil contains absorbable polyglycolic acid (PGA) suture whereas the Stretch Resistant MicroCoil contains
non-absorbable nolveropylone auture non-absorbable polypropylene suture.
The Modified MicroCoils are available in both stretch resistant and non-stretch resistant configurations with different stiffers resistant and non-stretch
illustrates the softness characteristics and character illustrates the softness characteristics and stretch resistant properties of the various size/shape combinations available for the Modified MicroCoil.
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035 803
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Modified MicroCoil ("Cerecyte") Shape/Size Combinations and Resulting Characteristics
| CatalogueDesignation | Shape | Diameter"mm" | Length"cm" | StretchResistant(Yes/No) | Characteristics |
|---|---|---|---|---|---|
| Helical Modified Coils | |||||
| "CFS" | Helical | 2–4 | 1–8 | Yes | Soft finishing coil• 0.0015"platinum wire |
| "CHS" | Helical | 2–10 | 1–30 | Yes | Regular filling coil• 0.00175"platinum wire |
| "CHE" | Helical | 2–10 | 1–30 | No | Regular filling coil• 0.002"platinum wire |
| Spherical Modified Coils | |||||
| "CSS" | Spherical | 2–4 | 2.5–7.5 | Yes | Soft framing coil• 0.00175"platinum wire |
| "CSP" | Spherical | 2–10 | 2.5–20.5 | No | Regular framingcoil• 0.002"platinum wire |
The Modified MicroCoils maintain the same design features as the current Micrus MicroCoil Systems. Compared with the current design, Modified MicroCoils have:
MicroCoil Systems. Compared with the current design, Modified MicroCoils have:
. . . . The sam
- The same intended use ●
- Connect to the same connecting cables .
- Detach using the same Detachment Control Box. .
It is important to reiterate, the Micrus Modified MicroCoils are identical to the current CE Marked / The Micros Mounted MicroColls are identical to the following 2 exceptions:
- Non-Stretch Resistant Modified MicroCoils Spacing. The current non-1. stretch resistant MicroColl uses 0.00175" platinum wire wound with a 0.00175" pitch or 0.002" platinum wire wound with a 0.002" pitch. The Modified non-stretch resistant MicroCoil uses 0.002" pitch. The wound with a 0.004" pitch.
- Absorbable suture in all Modified MicroCoils: Biocompatible, absorbable 2. sure has been inserted inside the primary wind of all Modified MicroCoils.
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Page 3 of 14
Comparison of Current and Modified Non-Stretch Resistant MicroCoils
Image /page/2/Figure/4 description: The image shows a diagram of a "Current Micrus Non-Stretch Resistant MicroCoil". The diagram labels the different parts of the microcoil, including the DPU, detachment fiber, coil, and platinum ball tip. According to the text, the current FDA cleared MicroCoil configuration has a platinum ball tip, no suture, and a 0.00175" or 0.002" pitch.
Image /page/2/Figure/5 description: This image shows a diagram of a modified non-stretch resistant microcoil. The diagram labels the different parts of the microcoil, including the DPU, detachment fiber, wide pitch coil, PGA suture, and polypropylene ball tip. The modified configuration has a polyethylene ball tip, PGA suture inside the primary wind that does not extend to the detachment zone, and a 0.004" pitch.
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ise
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Comparison of Current and Modified Stretch Resistant MicroCoils
Image /page/3/Figure/3 description: This image shows a diagram of a "Current Micrus Stretch Resistant MicroCoil". The diagram labels the different parts of the microcoil, including the DPU, detachment fiber, coil, polypropylene suture, and polypropylene ball tip. The text at the bottom of the image describes the current configuration, which includes a polypropylene ball tip, a polypropylene suture that extends to the detachment zone, and a 0.00175" or 0.002" pitch.
Image /page/3/Figure/4 description: The image shows a "Modified Stretch Resistant MicroCoil". The different parts of the microcoil are labeled, including the DPU, detachment fiber, coil, PGA suture, and polypropylene ball tip. The modified configuration has a polyethylene ball tip, PGA suture inside the primary wind that extends to the detachment zone, and 0.0175" or 0.002" pitch.
{4}------------------------------------------------
E. Intended Use
Page 5 of 14
Intended Use of the Micrus Modified MicroCoil Delivery System per the IFU: The MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Intended Use of the Predicate Micrus MicroCoil Delivery System per the IFU: The MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
{5}------------------------------------------------
Technological Comparison
MicroColl System
に
Microcoil System
| Characteristic | Micrus MicroCoil System Predicate | Micrus Stretch Resistant Predicate | Micrus Modified MicroCoil System |
|---|---|---|---|
| How Supplied | Sterile, Single Use | Sterile, Single Use | Same as predicates |
| MicroCoil attached to DPU. | Coil attached to pusher wire. | Same as predicates | |
| Polyethylene introducer over coil. | Polyethylene introducer over coil. | Same as predicates | |
| In plastic packaging hoop. | In plastic packaging hoop. | Same as predicates | |
| Characteristic | Micrus MicroCoil Predicate | Micrus Stretch ResistantPredicate | Micrus Modified MicroCoilSystem |
| Materials ofConstruction | Platinum/Tungsten alloy wire &Au/Sn solder. | Platinum/Tungsten alloy wire &Au/Sn solder. | Same as predicates |
| Shape | No suture | Polypropylene suture. | PGA suture |
| Dimensions | 2 mm – 30 mm | 2 mm – 15 mm | 2 – 30 cm |
| 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 DPU | High tensile strength, highlyoriented polyethylene fiber. | High tensile strength, highlyoriented polyethylene fiber. | Same as predicates |
| Method ofDetachment fromDPU | Shear polyethylene fiber with aloop of resistively heated coil. | Shear polyethylene fiber with aloop of resistively heated coil. | Same as predicates |
| Provided: | Sterile, single use | Sterile, single use | Same as predicates |
lmplantable Embolic Coil
K033803
{6}------------------------------------------------
Device Positioning Unit
| Positioning Unit Characteristic | Micrus MicroCoil Predicate | Micrus Stretch Resistant Predicate | Micrus Modified MicroCoil System |
|---|---|---|---|
| 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.Stainless steel hypotube (proximal), stainless steel braid (mid) and polymer (distal) sheathing for 2 conduction wires and distal RH coil. | 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.Stainless steel hypotube (proximal), stainless steel braid (mid) and polymer (distal) sheathing for 2 conduction wires and distal RH coil. | Same as predicatesSame as predicatesSame as predicates | |
| Length | 195 cm | 195 cm | Same as predicates |
| Package Configuration | In plastic packaging hoop.Introducer in place (for introduction of MicroCoil into the microcatheter).Low density polyethylene & polyester outer package | In plastic packaging hoop.Introducer in place (for introduction of coil into the microcatheter).Low density polyethylene & polyester outer package | Same as predicatesFoil pouch with a low density polyethylene coating on inside and polyester coating on outside |
| 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).2 radiopaque tip markers 3 cm apart (examples: Tracker 10, Tracker 18, Excel 14, Prowler 10, Prowler 14). | Same as predicates "10" sized systemsSame as predicates |
KOSS 803
Pizze Fof 14
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Connecting Cables (Unchanged for Micrus Modified MicroCoi
| Characteristic | Micrus MicroCoil Predicate | Micrus Stretch ResistantPredicate | Micrus Modified MicroCoilSystem |
|---|---|---|---|
| How supplied | Sterile, single use | Sterile, single use | Same as predicates |
| Physical | Single cable with proprietaryconnectors to fit only the MicrusDetachment Control Box and theMicrus MicroCoil System | Single cable with proprietaryconnectors to fit only the MicrusDetachment Control Box and theMicrus MicroCoil System | Same as predicates |
| Length | 262 cm. | 262 cm. | Same as predicates |
Detachment Control Box (Unchanged for Micrus Modified MicroCoil)
| Characteristic | Micrus MicroCoil Predicate | Micrus Stretch Resistant Predicate | Micrus Modified MicroCoil System |
|---|---|---|---|
| How supplied | Non-Sterile, reusable. | Non-Sterile, reusable. | Same as predicates |
| Power Source | Used outside the sterile field. | Used outside the sterile field. | Same as predicates |
| Displays | Alkaline batteries. | Alkaline batteries. | Same as predicates |
| Voltage, Current, Low Battery, Fault, Detach Cycle | Voltage, Current, Low Battery, Fault, Detach Cycle | Same as predicates | |
| Detachment Cycle Duration | 5 seconds | 5 seconds | Same as predicates |
| Output Voltage | 6.5 VDC | 6.5 VDC | Same as predicates |
| Output Current | 125 mA nominal, 200 mA max. | 125 mA nominal, 200 mA max. | Same as predicates |
Kogs805 Page 8 of 14
{8}------------------------------------------------
Detachment Control Box Continued (Unchanged for Micrus Modified Mic
| Detachment Control Box Continued (Unchanged for Micrus Modified MicroCoil) | |||
|---|---|---|---|
| Characteristic | Micrus MicroCoil Predicate | Micrus Stretch Resistant Predicate | Micrus Modified MicroCoil System |
| "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. | "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. | Same as predicates |
| Method to attachConnecting Cable toDetachment Box | Proprietary connector; fits onlyone-way to assure proper polarity. | Proprietary connector; fits onlyone-way to assure proper polarity. | Same as predicates |
| 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 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. | Same as predicates |
Koss 8033805 Page Got 14
f 16
{9}------------------------------------------------
Accessories
| Characteristic | Accessory ProductsRequired to Performthe Procedure. | Micrus MicroCoil Predicate | Micrus Stretch Resistant Predicate | Micrus Modified MicroCoilSystem |
|---|---|---|---|---|
| *- Not provided as partof the system, chosenbased upon physicianexperience andpreference. | Micrus Sterile Connecting Cable | Micrus Sterile Connecting Cable | Same as predicates | |
| Micrus Detachment Control Box | Micrus Detachment Control Box | Same as predicates | ||
| 5-7F Guide Catheter* | 5-7F Guide Catheter* | Same as predicates | ||
| 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 demonstilly equivalent technologies used in the Micrus Morifed MicroCoil Delivery
System as compared with the 2 predicate MicroCoil Systems: (1)
KO33803 Page 10 of 14
{10}------------------------------------------------
iscussion of Non-Clinical Tests and Conclusio G.
The non-cinical tests periormed on the MicroColl System were based toe of the device, ite performan
the predicale devices Microcoll Delivery System and the Microchi System) a
he following table outlines the important device characteristics and the non-clinical test of also
| Test | Micrus Modified MicroCoil System Test Result | Substantial Equivalence |
|---|---|---|
| Acute Animal TestingV0327-acute outcome | Characteristic: Aneurysm occlusion and detachment reliability.Test data: Coils detached with the first detachment cycle in > 95% of detachments and ≥90% aneurysm occlusion was obtained in all 5 aneurysms. | Substantially equivalent. |
| Chronic Animal Testing forCoil Stability &Aneurysm OcclusionV0327-chronic outcome | 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. Histology showed chronic biocompatibility per study V0401. | Substantially equivalent. |
| Coil Stiffness/Softness forWide Pitch ModifiedMicroCoilsV0396 | Characteristic: Stiffness limits for the modified coils manufactured with a looser wind (wide pitch). No change was made that would affect the stiffness of the tightly wound coils.Test data: The loosely wound (wide pitch) Helical and Spherical Modified MicroCoils met the stiffness specifications. | Substantially equivalent. |
| Friction in the Microcatheter(Delivery Force)V0429 | Characteristic: Average push force must be substantially equivalent to predicates.Test data: The Modified MicroCoil had average push forces that are comparable to those of the predicate. | Substantially equivalent. |
| Biocompatibility of MaterialsV0401 & V0435 | Characteristics: Meets the requirements of ISO 10993.Test data: The only new material in the Micrus Modified MicroCoil is absorbable suture, which passed ISO 10993 biocompatibility testing. | Meets ISO 10993 |
Koss 811 Fire
{11}------------------------------------------------
| Sterilization Validation | Characteristic: | |
|---|---|---|
| V0394 | Characteristic: Minimum Sterility Assurance Level of 10-6.Test data: Passed minimum sterility assurance level of 10-6. | Substantially equivalent. |
| Shelf Life TestV0397 | Characteristic: No performance degradation after 3 year of shelf life aging.Test data: Minimum tensile strength after 3 year accelerated aging shows no degradation. | Substantially equivalent |
| Tensile Strength: StretchResistant ModifiedMicroCoils (at thedetachment zone, PGA topolypropylene junction andsuture ball tip to MicroCoil)V0427 | Characteristic: Pre-detachment tensile strength of the suture ball tip and MicroCoil to DPU must be substantially equivalent to the stretch resistant predicate.Test data: Tensile strength meets desired strength criteria. | Substantially equivalentto the stretch resistantpredicate |
| Tensile Strength: Non-Stretch Resistant ModifiedMicroCoils (at thedetachment zone)V0398 | Characteristic: Pre-detachment tensile strength of the MicroCoil to DPU must be substantially equivalent to the non-stretch resistant predicate.Test data: Tensile strength meets desired strength criteria. | Substantially equivalentto the non-stretchresistant predicate |
| Tensile Strength: Non-Stretch Resistant (at thesuture ball tip)V0428 | Characteristic: Pre-detachment tensile strength of the suture ball tip and MicroCoil must be substantially equivalent to the non-stretch resistant predicate.Test data: Tensile strength meets desired strength criteria. | Substantially equivalentto the non-stretchresistant predicate |
| Durability (Reliability afterFatigue)V0405 | 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 |
| MRI Compatibility ofImplant | No change was made which would impact MRI compatibility. | Substantially equivalent |
KO358LS
July 17 of 14
f
{12}------------------------------------------------
| Package Integrity | Characteristic: Demonstrate package integrity per ISO 11607 | Meets ISO 11607 criteria |
|---|---|---|
| V0399 | Test: Meets ISO 11607 criteria | |
| Ship/TransitV0400 | Characteristic: Successfully withstand domestic and internationaldistribution environmentTest: Does successfully withstand domestic and internationaldistribution environment. | Substantially equivalent |
This nor-clinical testing has demonstrated the substantially equivalent performance of the MicroColl System with the s
predicale devices: (1) Micrus MicroColl Delivery System
K033843
Page 13 of 14
{13}------------------------------------------------
KA33815
Page 14 of 14
Summary of Safety and Effectiveness H.
Based upon the design, materials, function, intended use, comparison with
currently market devices and the non-clinical testing performed by the many is
Corporation, it is co Delivery System in safety and effectiveness.
lik 1 ..............................................................................................................................................................................
Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation December 5, 2003
{14}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is black against a white background. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/14/Picture/3 description: The image shows a partial view of a logo or emblem. The visible portion includes a stylized graphic element, possibly representing a natural form like a plant or wave, rendered in black. Adjacent to this graphic is a segment of text arranged in a circular fashion, also in black, suggesting the name or title of the organization or entity the logo represents. The text is oriented along the curve of a circle, indicating it is part of a larger circular design.
FEB - 4 2004
Ms. Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, California 94085
Re: K033813
Trade/Device Name: Micrus Modified Microcoil System, Cerecyte Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: December 5, 2003 Received: December 9, 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 Mcdical 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 cither 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 not the Act or any liedcral 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 eccerver product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{15}------------------------------------------------
Page 2 - Ms. Margarct 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), plcasc 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) 638-201 or 1 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
(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
{16}------------------------------------------------
Indications for Use
510(k) Number (if known): K033813
Device Name:
Micrus Modified Microcoil System, Cerecyte
Indications For Use:
The Micrus MicroCoil Delivery System is intended for
endovascular embolization of intracranial aneurysms.
× Prescription Usc (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
10(%) Number_K633813
Page 1 of _
§ 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).