Micrus MicroCoil Systems are platinum embolic coils ("MicroCoils") attached to Device Positioning Units (DPUs (single use, sterile). The Micrus MicroCoil Systems are available in a 10-System size (compatible with 10 and 14 sized microcatheters) and 18-System size (compatible with 14 and 18 sized microcatheters). Both 10 and 18 sizes are available in various diameters/dimensions. Shapes can be spherical, helical, or straight. Lengths range from 1 to 30 centimeters and diameters range from 2 to 20 millimeters. Implant material for the non stretch resistant MicroCoils is a platinum alloy: implant material for the stretch resistant MicroCoils is a platinum alloy and a stretch resistant member (non-absorbable polypropylene suture).

A MicroCoil is detached from its Device Positioning Unit through heat shearing of a highly oriented, high tensile strength polyethylene (PE) fiber upon the clinician's command. The Device Positioning Unit is then removed from the microcatheter and discarded.

A Micrus 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. A MicroCoil System plus Connecting Cable and Detachment Control Box is referred to as a Micrus MicroCoil Delivery System.

AI/ML Overview

This response is structured based on the provided document, K031578. The information regarding acceptance criteria and the study that proves the device meets them is primarily found in sections G and H.

Acceptance Criteria and Device Performance Study for Micrus MicroCoil Systems

This submission focuses on a labeling change for the Micrus MicroCoil Systems, specifically a change to the "Indication for Use" statement based on clinical outcomes from the International Subarachnoid Aneurysm Trial (ISAT). The device itself (Micrus MicroCoil System) remains unchanged from its predicate devices K002056 and K022420. Therefore, the device's technical acceptance criteria were established and met in the predicate device clearances, and the current submission provides a summary of those non-clinical tests. The "study that proves the device meets the acceptance criteria" in this context refers to the clinical evidence (ISAT) used to justify the broader indication for use.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)

The following table summarizes the non-clinical tests and results, previously reviewed for the predicate devices, for which the Micrus MicroCoil System was found "Equivalent." These represent the fundamental performance acceptance criteria for the device itself.

Test / Characteristic	Acceptance Criteria	Reported Device Performance
Aneurysm Packing / Detachment Reliability	- Complete occlusion of aneurysms. - Detachment reliability.	- 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.
Coil Stability / Aneurysm Occlusion	- Positional stability and aneurysm occlusion.	- Positional stability and aneurysm occlusion maintained through 6 months of implant. - No coil compaction present at 6-month angio.
GDC Bench Marking	- Established specifications for delivery force, tensile strength, and stiffness. - Micrus Stretch Resistant MicroCoil must be substantially equivalent to predicates.	- Showed substantial equivalence in delivery force, tensile, and stiffness.
Coil Stiffness/Softness	- Stiffness limit desired for Finishing Stretch Resistant MicroCoil.	- Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil stiffness is within desired stiffness limit.
Friction in the Microcatheter (Delivery Force)	- Average push force must be substantially equivalent to predicates.	- Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil average push force exhibit comparable delivery forces.
MDR Database Review	- Review for clinical risks.	- MSR01 risk assessment includes and addresses all risks encountered in review of predicate device MDR review.
Biocompatibility of Materials	- Meets the requirements of ISO 10993.	- The only new material in the Micrus Stretch Resistant MicroCoil is polypropylene monofilament # 6523, which is identical to the pre-approved GDC stretch resistant suture. (Implies compliance by equivalence to approved material).
Sterilization Validation	- Minimum Sterility Assurance Level of 10-6.	- Passed minimum sterility assurance level of 10-6.
Shelf Life Test	- No performance degradation after 1 year of shelf life aging.	- Minimum tensile strength after 1 year accelerated aging shows no degradation.
Tensile Strength	- Tensile strength of suture ball tip and MicroCoil to DPU must be substantially equivalent to predicates.	- Tensile strength meets desired strength criteria.
Durability (Reliability after Fatigue)	- Withstand deployment and retraction 6 times in a tortuous anatomy.	- No knotting, no breakage, no stretching occurred. - Durability meets desired durability criteria.
MRI Compatibility of Implant	- No change impacting MRI compatibility.	- No change was made which would impact MRI compatibility. (Implies existing compatibility from predicates is maintained, thus meets this inherent criterion).

Acceptance Criteria for Clinical Outcomes (New Indication for Use):

The acceptance criteria for the expanded "Indication for Use" are implicitly derived from the results of the ISAT study, which demonstrated clinical superiority of endovascular coiling over surgical clipping for ruptured intracranial aneurysms.

Clinical Outcome Parameter	Acceptance Criteria (based on ISAT findings)	Reported Device Performance (ISAT results for endovascular patients, including Micrus MicroCoils)
Dependency or Death at 1 Year (Primary Outcome)	Significantly better outcome (lower incidence of dependency or death) for endovascular coiling compared to surgical clipping.	23.7% of endovascular patients were dependent or dead at 1 year. (Compared to 30.6% for surgical patients).
Relative Risk Reduction	Positive relative risk reduction demonstrating benefit of endovascular coiling.	22.6% relative risk reduction for endovascular patients versus surgical.
Absolute Risk Reduction	Positive absolute risk reduction demonstrating benefit of endovascular coiling.	6.9% absolute risk reduction for endovascular patients versus surgical.
Risk of Rebleeding at 1 Year	Acceptably low risk of rebleeding, even if slightly higher than surgical clipping, given overall outcome benefits.	2 per 1276 for endovascular patients. (Compared to 0 per 1081 for surgical patients).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Clinical Test Set (ISAT):
- Total patients enrolled: 2143
- Patients randomly assigned to endovascular treatment with platinum coils: 1073
- Patients randomly assigned to neurosurgical clipping: 1070
Data Provenance: The study was a "multi-center study published in the Lancet," referred to as the International Subarachnoid Aneurysm Trial (ISAT). It involved patients with ruptured intracranial aneurysms. The data is prospective as it involved random assignment and follow-up. The document does not explicitly state the countries of origin for all participating centers, but "International" implies multiple countries, likely involving European and other centers given its publication in The Lancet and prior clinical practice in Europe. Micrus Corporation received CE Marking in May 2000 and FDA clearance in January 2001, joining ISAT in February 2001, indicating its international scope prior to US market entry.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ISAT study was a large, randomized controlled trial comparing two treatment modalities for ruptured intracranial aneurysms. The "ground truth" for the primary outcome (neurological assessment of dependency at 1 year) was established through clinical outcomes data collected directly from patients. The document states, "The primary outcome was a neurological assessment of dependency at 1 year (using the Rankin neurological outcome scale)." This implies that trained clinical personnel (e.g., neurologists, nurses, or other healthcare professionals) conducted these assessments. The exact number of experts/assessors is not specified, but for a trial of this magnitude, it would involve numerous qualified healthcare professionals at each participating center, following standardized protocols for outcome assessment. Their qualifications would be as medical professionals trained in neurological assessment and the use of the Rankin scale.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the primary outcome assessment itself (neurological assessment of dependency). For large, multi-center trials like ISAT, it is common best practice to have:

Standardized training for assessors.
Centralized review of case report forms.
Possibly masked outcome assessment (though not explicitly stated whether assessors were blinded to treatment arm).
A Clinical Events Committee (CEC) to adjudicate serious adverse events or difficult-to-classify outcomes.
The text primarily focuses on the direct "Findings" from the collected data, implying a robust methodology for data collection and analysis rather than a specific "adjudication" of the primary outcome by external experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done as part of this submission or the ISAT. ISAT was a randomized controlled trial comparing treatment modalities (endovascular coiling vs. surgical clipping) and their clinical outcomes, not comparing human reader performance with or without AI assistance. The Micrus MicroCoil System is a physical device, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not conducted. The Micrus MicroCoil System is a medical device, not an algorithm or AI system for diagnosis or standalone analysis. Its performance is assessed through its physical characteristics and clinical outcomes when used in patients.

7. Type of Ground Truth Used for the Clinical Test Set (ISAT)

The ground truth used for the clinical test set (ISAT) was outcomes data, specifically:

Clinical outcomes: Neurological assessment of dependency at 1 year using the Rankin neurological outcome scale.
Survival data: Implied by "dependent or dead at 1 year."
Rebleeding events: Documented occurrence of rebleeding at 1 year.
This is direct patient outcome data, collected prospectively as part of the randomized controlled trial.

8. Sample Size for the Training Set

For the non-clinical tests (physical performance, durability, etc.): Not applicable in the context of "training set" as these are engineering and materials tests, not machine learning based.
For the clinical justification (ISAT): Not applicable. ISAT was a clinical trial used for validation/comparison, not a "training set" for a device, as the Micrus MicroCoil System is a physical medical device and not a data-driven model requiring a training phase for its core function.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no explicit "training set" in the context of an AI/ML algorithm or data-driven model described in this submission. The "ground truth" for evaluating the clinical efficacy of the device (as part of endovascular coiling) was established through the rigorous, prospective data collection and follow-up within the ISAT clinical trial design.

Summary

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K031578

Safety and Effectiveness Summary II.

A. Contact Information

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085

Device Name B.

Micrus MicroCoil System Classification: Device, Artificial Embolization Regulation Number: 882.5950 Product Code: HCG Device Class: III

C. Predicate Device(s)

This 510k application is for a labeling change to the FDA cleared Micrus MicroCoil Systems listed in the table below:

Number	Description	Clearance Date
K002056	Micrus MicroCoil Delivery System	01/11/2001
K022420	Micrus Stretch Resistant MicroCoil System	10/22/2002

Device Description: Unchanged from predicates listed above. D.

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Intended Use (Indication for Use Statement) E.

Micrus MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

Technological Comparison F.

There is no change in the technology from that of 510k numbers K002056 and K022420. The Micrus MicroCoil System remains the same. The only change is the Indication for Use (to be justified in the Section I, "Justification for Labeling Change Based Upon Clinical Outcomes of ISAT"

	MicroCoil System (Unchanged)
Characteristic	Micrus MicroCoil System Predicate	Current Application
MicroCoil	Sterile, single use.	Same as predicate
System	MicroCoil attached to DPU.	Same as predicate
supplied as:	Polyethylene introducer over coil.	Same as predicate
	In plastic package hoop.	Same as predicate

Implantable Embolic Coil (Unchanged)
Characteristic	Micrus MicroCoil System Predicate	Current Application
Materials ofConstruction	Platinum/Tungsten alloy wire &Au/Sn solder	Same as predicate
Shape	Spherical, helical, & straight	Same as predicate
Dimensions	Various diameters & lengths to treata variety of aneurysm sizes	Same as predicate
Radiopacity	Radiopaque from Pt alloy wire	Same as predicate
MRICompatibility	Yes	Same as predicate
Method ofAttachment toDevicePositioningUnit	High tensile strength, highlyoriented polyethylene fiber	Same as predicate
Method ofDetachmentfrom DevicePositioningUnit	Shear polyethylene fiber with a loopof resistively heated coil	Same as predicate
Provided:	Sterile, single use	Same as predicate

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Device Positioning Unit (Unchanged)
Characteristic	Micrus MicroCoil System Predicate	Current Application
Physical	Variable stiffness.Composite introducer.Most flexible distally, mediumflexibility in mid-section and stiffestproximally to allow pushing of theembolic coil through the tortuouscerebral vasculature.	Same as predicate
Construction	Stainless steel hypotube (proximal),stainless steel braid (mid) andpolymer (distal) sheathing for 2conduction wires and distal RH coil.	Same as predicate
WorkingLength	175 cm	Same as predicate
PackageConfiguration	In plastic packaging hoop.Introducer in place (for introductionof MicroCoil into the microcatheter).	Same as predicate
Compatiblewith:	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 predicate

Connecting Cable (Unchanged)
Characteristic	Micrus MicroCoil Delivery SystemPredicate	Current Application
How supplied:	Sterile, single use	Same as predicate
Physical	Single cable with proprietaryconnectors to fit only the MicrusDetachment Control Box and theMicrus MicroCoil System	Same as predicate
Length	262 cm.	Same as predicate

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Detachment Control Box (Unchanged)
Characteristic	Micrus MicroCoil Delivery SystemPredicate	Current Application
How supplied	Non-Sterile, reusable.Used outside the sterile field.	Same as predicate
Power Source	Alkaline batteries.	Same as predicate
Displays	Voltage, Current, Low Battery,Fault, Detach Cycle	Same as predicate
DetachmentCycleDuration	5 seconds	Same as predicate
OutputVoltage	6.5 VDC	Same as predicate
OutputCurrent	125 mA nominal, 200 mA max.	Same as predicate
"Detach"feedback	"Detach Cycle" light goes fromilluminated to off. Also, a beepsounds once a second for 5 secondsto provide an audible countdown ofthe 5 second detachment time.Clinician verifies detachmentfluoroscopically per device labeling.	Same as predicate
Method toattachConnectingCable toDetachmentBox	Proprietary connector; fits only one-way to assure proper polarity.	Same as predicate
Flow ofCurrent	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.	Same as predicate

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Accessories (Unchanged)
Characteristic	Micrus MicroCoil SystemPredicate	CurrentApplication
AccessoryProducts Requiredto Perform theProcedure.	Micrus Sterile Connecting Cable	Same as predicate
	Micrus Detachment Control Box	Same as predicate
	5-7F Guide Catheter*	Same as predicate
	Microcatheter (see above)*	Same as predicate
	Guide wire compatible with microcatheter*	Same as predicate
	Continuous saline/heparin saline flush*	Same as predicate
* - Not provided aspart of the system,chosen based uponphysicianexperience andpreference.	Rotating haemostatic valves*	Same as predicate
	3-Way stopcock*	Same as predicate
	1-Way valve*	Same as predicate
	IV pole*	Same as predicate
	Femoral Sheath*	Same as predicate
	Alkaline Batteries*	Same as predicate

This technological comparison demonstrates the Micrus MicroCoil Delivery System remains equivalent to 510k numbers K002056 and K022420

Discussion of Non Clinical Tests and Conclusions (Unchanged) G.

The non-clinical tests performed on the Micrus MicroCoil System were reviewed in 510k numbers K002056 and K022420. A summary of non-clinical tests and results are supplied here as a reference.

Test	Results (Unchanged)	SubstantialEquivalence
Aneurysm Packing /DetachmentReliability	Characteristic:■ Complete occlusion ofaneurysms.■ Detachment Reliability.Test data:■ No filling defects evident onangio.■ No premature detachment /auto-detach caused byexposure to blood, bodyfluids, body temperatures orrepeated manipulation. 100%first detach-cycle detachmentachieved.	Equivalent
Coil StabilityAneurysm Occlusion	Characteristic: Positionalstability and aneurysmocclusion.Test data: Positional stability andaneurysm occlusion maintainedthrough 6 months of implant. Nocoil compaction present at 6-month angio.	Equivalent
GDC BenchMarking	Characteristic: Establishedspecifications for delivery force,tensile strength, and stiffness.The Micrus Stretch ResistantMicroCoil must be substantiallyequivalent to predicates.Test data: Showed substantialequivalence in delivery force,tensile, and stiffness.	Equivalent
CoilStiffness/Softness	Characteristic: Stiffness limitdesired for Finishing StretchResistant MicroCoil.Test data: Finishing StretchResistant MicroCoil and HelicalStretch Resistant MicroCoilstiffness is within desiredstiffness limit.	Equivalent
Friction in theMicrocatheter(Delivery Force)	Characteristic: Average pushforce must be substantiallyequivalent to predicates.Test data: Finishing StretchResistant MicroCoil and HelicalStretch Resistant MicroCoilaverage push force exhibitcomparable delivery forces.	Equivalent
MDR DatabaseReview	Characteristic: MDR review forclinical risks.Test data: MSR01 riskassessment includes andaddresses all risks encounteredin review of predicate deviceMDR review.	Equivalent
Biocompatibility ofMaterials	Characteristics: Meets therequirements of ISO 10993.Test data: The only new materialin the Micrus Stretch Resistant	Equivalent
	MicroCoil is polypropylenemonofilament # 6523. It isidentical to the pre-approvedGDC stretch resistant suture.
SterilizationValidation	Characteristic: MinimumSterility Assurance Level of 10-6.Test data: Passed minimumsterility assurance level of 10-6.	Equivalent
Shelf Life Test	Characteristic: No performancedegradation after 1 year of shelflife aging.Test data: Minimum tensilestrength after 1 year acceleratedaging shows no degradation.	Equivalent
Tensile Strength	Characteristic: Tensile strengthof suture ball tip and MicroCoilto DPU must be substantiallyequivalent to predicates.Test data: Tensile strength meetsdesired strength criteria.	Equivalent
Durability(Reliability afterFatigue)	Characteristic: Withstanddeployment and retraction 6times in a tortuous anatomy.Test data: No knotting, nobreakage, no stretching occurred.Durability meets desireddurability criteria.	Equivalent
MRI Compatibilityof Implant	No change was made whichwould impact MRIcompatibility.	Equivalent

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K031578

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Justification for Labeling Change of "Indication for Use" Statement H. Background

Endovascular coiling of intracranial aneurysms has been in clinical practice in Europe since 1992 and since 1995 in the U.S. Prior to the advent of safe, detachable coil systems, patients with intracranial aneurysms had only one option: craniotomy and clipping. In the past 10 years, coiling has gained acceptance world wide as a viable option to surgical clipping.

Initially, endovascular coiling was viewed as an alternative to be used only when surgery was ill advised due to an aneurysm's shape or location, or to a patient's poor condition. Therefore, initially it was appropriate to label coils as intended for use in cases where the surgery was deemed to be high risk or impossible.

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K031578

Over the past 10 years many improvements have been made in endovascular techniques making coiling a superior option to surgery, as demonstrated in a recent multi-center study published in the Lancet. The purpose of the study was to compare outcomes of endovascular coiling to surgical clipping. Based upon the results of this study, in which MicroCoils were used (along with GDC and Cook coils) Micrus Corporation is requesting a change to its "Indication for Use" statement.

Micrus Corporation received CE Marking for the Micrus MicroCoil System in May 2000. followed by FDA market clearance in January 2001. After regulatory clearance, Micrus applied to the International Subarachnoid Aneurysm Trial Steering Committee for inclusion in their multi-center study. Permission was granted in February 2001. MicroCoils continued to be used in the study until study enrollment ended in June 2002.

Brief Overview of the International Subarachnoid Aneurysm Trial (ISAT)

Reason for the Study

ISAT was designed to establish the relative benefits of endovascular coiling versus surgical clipping for intracranial aneurysms in patients with ruptured intracranial aneurysms.

Methods

ISAT enrolled 2143 patients with ruptured intracranial aneurysms and randomly assigned them to neurosurgical clipping (n = 1070) or endovascular treatment with platinum coils (n = 1073).
· Clinical outcomes were assessed at 2 months and at 1 year.
The primary outcome was a neurological assessment of dependency at 1 year (using the Rankin neurological outcome scale).

Findings

23.7% of endovascular patients were dependant or dead at 1 year.
30.6% of surgical patients were dependant or dead at 1 year.
The relative risk reduction for endovascular patients (versus surgical) was 22.6%.
The absolute risk reduction for endovascular patients (versus surgical) was 6.9%.
The risk of rebleeding at 1 year for the endovascular patients was 2 per 1276.
The risk of rebleeding at 1 year for the surgical patients was 0 per 1081. Interpretation
The outcome in terms of survival, free of disability at 1 year, is significantly better with endovascular coiling.
Long-term risks of further bleeding are low from either therapy, although slightly more frequent with endovascular coiling.

Proposed Labeling Change to "Instruction for Use" pamphlet

Based upon the results of ISAT, Micrus Corporation proposes changing the current "Indication for Use" statement.

The proposed "Indication for Use" labeling is as follows:
The ACT Platinum MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

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Kc31578

Summary of Safety and Effectiveness l.

Based upon the clinical trail results cited in the Lancet, it is concluded that the Micrus MicroCoil System (one of 3 platinum embolic coil systems used in this scientifically rigorous randomized trial) demonstrated treatment outcome is significantly better with endovascular coiling than with surgical clipping.

Margaret Webber Director, Regulatory & Clinical Affairs Micrus Corporation May 07, 2003

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Ms. Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, California 94085

Re: K031578

Trade/Device Name: Micrus MicroCoil Systems Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: May 7, 2003 Received: June 3, 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 premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Margaret Webber

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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) you may obtain. 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,

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

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K 03/578

Device Name: Micrus MicroCoil Systems

510(k) Number (if known):

Indications for Use:

Micrus MicroCoil Systems are 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: V (Per 21 CFR 801.109)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031578

=: |

Regulation Number and Section

§ 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).