The Micrus Modified MicroCoil 18-System (Cerecyte) consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Cerecyte 18-System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.017" and 0.021." The coils are available in helical and spherical shapes and are available in various diameters/lengths: Coil lengths range from 4 to 30 centimeters. Coil diameters range from 2 to 20 millimeters. Micrus Cerecyte 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 only difference between the Cerecyte 18 System and 10 System is size. Both contain PGA suture as their stretch resistant member. Both contain exactly the same PGA strand, i.e., the amount of PGA suture material is identical. Micrus does not insert a larger strand of suture in the 18 system coils. The 18 System Cerecyte MicroCoils maintain the same design features as all the current MicroCoil Systems. Compared with the current design, size 18 Cerecyte MicroCoil Systems have: The same intended use. Connect to the same connecting cables Detach using the same Detachment Control Box.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided for the Cerecyte-18 MicroCoil System:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Characteristic	Reported Device Performance / Test Data	Substantial Equivalence Status
Coil Stiffness/Softness for Cerecyte-18 MicroCoils	The Cerecyte-18 MicroCoils met the stiffness specifications.	Substantially equivalent
Friction in the Microcatheter (Delivery Force)	The Modified MicroCoil had average push forces that are comparable to those of the predicate.	Substantially equivalent
Tensile Strength	Tensile strength meets desired strength criteria. (Specifically, pre-detachment tensile strength of the suture ball tip and MicroCoil to DPU must be substantially equivalent to the stretch resistant Cerecyte-10 predicate)	Substantially equivalent to the stretch resistant predicate
Durability (Reliability after Fatigue)	No knotting, no breakage, no stretching occurred (after withstanding deployment and retraction 6 times in a tortuous anatomy). Durability meets desired durability criteria.	Substantially equivalent
Sterilization Validation	Cerecyte-10 was validated under V0394 with a minimum Sterility Assurance Level of 10-6. Due to significant similarities (materials, manufacturing, product weight/density, packaging) between 10 & 18 Systems, V0394 serves as validation for the 18-system.	Substantially equivalent
MRI Compatibility of Implant	No change was made which would impact MRI compatibility.	Substantially equivalent
Package Integrity	No change was made to packaging. Reference Cerecyte 10 test result V0399. (Characteristic: Demonstrate package integrity per ISO 11607)	Substantially equivalent
Ship/Transit	Does successfully withstand domestic and international distribution environment. No change was made to packaging or product materials. Reference Cerecyte 10 test result V0400. (Characteristic: Successfully withstand domestic and international distribution environment)	Substantially equivalent

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the specific numerical sample sizes used for each test (e.g., how many coils were tested for stiffness, or how many deployments for durability). Instead, it describes the characteristics that were tested and the results.
Data Provenance: The tests were performed by "Micrus Endovascular Corporation" (the manufacturer). The testing is implied to be prospective, laboratory-based functional testing on the device itself. No information is provided regarding the country of origin of the data beyond being generated by the company. The document does reference previous predicate device testing results (e.g., Cerecyte 10 System) to demonstrate substantial equivalence for some characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document describes physical and functional testing of a medical device, not a diagnostic or prognostic AI/ML algorithm that requires expert-established ground truth. The acceptance criteria relate to engineering performance, sterility, and physical properties.

4. Adjudication method for the test set:

This information is not applicable for the same reason as above. The testing involves measurable physical and performance characteristics, not subjective interpretations requiring adjudication.

5. 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:

This information is not applicable. The device (Cerecyte-18 MicroCoil System) is a physical medical implant used for embolization of intracranial aneurysms. It is not an AI/ML diagnostic tool or software-as-a-medical-device (SaMD) that would be used by human readers (e.g., radiologists) for interpretation assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is not an algorithm.

7. The type of ground truth used:

For the physical and functional tests (stiffness, friction, tensile strength, durability, package integrity, ship/transit): The ground truth is based on engineering specifications and established functional criteria that align with safety and efficacy requirements for medical devices of this type. This is determined internally by the manufacturer and often aligns with industry standards or regulatory guidance.
For sterilization: The ground truth is based on achieving a Sterility Assurance Level (SAL) of 10^-6, which is a recognized regulatory standard for sterile medical devices.
For MRI compatibility: The ground truth is based on the absence of changes that would impact MRI compatibility, which implies adherence to standards or previous testing for the predicate device.

8. The sample size for the training set:

This information is not applicable as the device is a physical medical implant, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable as the device is a physical medical implant, not an AI/ML model.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K053160 1/8" in a handwritten style. The text is written in black ink on a white background. The numbers and letters are slightly uneven and have a rough texture, indicating that they were written by hand.

Section 1.4: Cerecyte-18, 510(k) Summary

Contact Information: 1.4.1

Name:	Margaret Webber, Director, Regulatory & Clinical Affairs
Address:	Micrus Endovascular Corporation610 Palomar Ave.Sunnyvale, CA 94085
Telephone:	408-830-5900, ext. 108
Date:	Nov. 28, 2005

Device Information 1.4.2

Micrus Modified MicroCoil, "Cerecyte" 18-System Device Name: Common Name: Device, Artificial Embolization Classification: Class II

Predicate Devices Identification 1.4.3

K033813, Micrus Modified Microcoil 10-System "Cerecyte" K002056, Micrus Microcoil Delivery System (10 and 18 sizes)

Device Description 1.4.4

The Micrus Modified MicroCoil 18-System (Cerecyte) consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile).

The predicate Cerecyte MicroCoil Systems in the 10-system size received FDA Clearance in February 2004. This application is for the 18-sized Cerecyte Microcoil System. The Cerecyte 18-System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.017" and 0.021." The coils are available in helical and spherical shapes and are available in various diameters/lengths:

Coil lengths range from 4 to 30 centimeters. .
Coil diameters range from 2 to 20 millimeters. .

Micrus Cerecyte 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 only difference between the Cerecyte 18 System and 10 System is size. Both contain PGA suture as their stretch resistant member. Both contain exactly the same PGA strand, i.e., the amount of PGA suture material is identical. Micrus does not insert a larger strand of suture in the 18 system coils.

The 18 System Cerecyte MicroCoils maintain the same design features as all the current MicroCoil Systems. Compared with the current design, size 18 Cerecyte MicroCoil Systems have:

The same intended use .
.
Connect to the same connecting cables ●
Detach using the same Detachment Control Box. .

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KOS3160

Image /page/1/Figure/1 description: This image shows the Micrus Modified MicroCoil System, Cerecyte, which is available in 10 and 18 system sizes. The image shows the different parts of the system, including the DPU, detachment fiber, coil, PGA suture, and PGA ball tip. The Cerecyte MicroCoil Systems (in 10 and 18 System sizes) have a PGA ball tip and a PGA suture that extends to the detachment zone.

Cerecyte 18-System coils size ranges are:

Helical Cerecyte (CHE) ranges from 2 -- 20 mm in diameter and from 4 -. 30 cm in length.
Spherical Cerecyte (CSP) ranges from 2 20 mm in diameter and 2.7 -. 30 cm in length.

Indications for Use 1.4.5

The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

Contraindications

None.

Required Accessory Products

The Micrus MicroCoil Systems require two other components for the Micrus MicroCoil Delivery System to operate:

1.Detachment Control Box (DCB). This device provides the energy to detach the MicroCoil from the DPU at the clinician's command. The DCB is provided NON-STERILE.

2.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 meters) long.

Accessories, which are an Integral Part of the Sales Unit:

The Micrus MicroCoil System is packaged with an introducer in place. This introducer allows introduction of the MicroCoil into the microcatheter used by the clinician.

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Accessories (Not Part of the Sales Unit, not supplied by Micrus Endovascular Corporation)

Guiding Catheter (generally, 5-7F) .
Infusion microcatheter with 2 tip markers located 3cm apart .
Guide wire compatible with the microcatheter ●
Continuous Saline Flush Set-Ups with pressure bags, one of which . is a flush for the guiding catheter and one the other a flush for the microcatheter.
Rotating Haemostatic Valves (2) .
3-Way Stopcock .
1-Way Valve .
IV Pole .
Femoral Sheath .

Comparison to Predicate 1.4.5

Intracranial aneurysms can form for a variety of reasons, and the consequences of aneurysm formation and/or rupture can be dire for the patient. Treatment of intracranial aneurysms involves the segregation of the sac from the blood supply of the parent artery. This prevents the aneurysm from growing in size, from rupturing or from re-rupturing. Treatments currently include the application of an aneurysm clip to the base of the aneurysm using open surgical procedures (craniotomy). Alternatively, the aneurysm may be embolically closed or occluded using minimally invasive delivery of embolic coils. Embolic coils are generally made of a biocompatible metal, such as stainless steel, tungsten or platinum. Dacron, nylon, or silk fibers may be incorporated into the design to enhance thrombosis. The coils come in a variety of widths, lengths, softness, and shapes and are delivered by small catheters ("microcatheters"). Multiple coils are placed into the aneurysm to completely fill the sac and prevent continued inflow of blood. The embolic coils cause stagnation of blood within the aneurysm resulting in platelet aggregation, which leads to the development of scar tissue. This prevents the continuing enlargement of the aneurysm and the potential fro rupture or re-rupture.

The intent of endovascular treatment of intracranial aneurysms using embolic coils is to pack the lumen of the aneurysm with the coils, thereby eliminating the influx of fresh blood into the lumen. The existing blood and soft clot trapped within the lumen of the aneurysm begins to solidify, ultimately becoming hardened clot and scar tissue. With treatment of the aneurysm lumen (from aneurysm dome to neck) a blood flow pathway is reestablished down the lumen of the parent artery, and the weakened wall of the aneurysm is totally isolated from arterial pressures. Reendothelialization occurs on the surface of the scar tissue, and the pretreatment vortical flow is changed back to normal, laminar flow within the parent artery.

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K053160

cranial aneurysms
oth, bare, platinum
4/

Micrus MicroCoil Systems have been used to treat intracranial aneurysms Micrus May 2000. MicroCoils are available in both bare platinum implants and stretch resistant implants containing either absorbable suture (PGA) or non-absorbable suture (polypropylene). Micrus MicroCoils are (1 Gr ) or mon abbere 10 and 18 sizes and in spherical and helical shapes in a variety of lengths and diameters.

Clinical data regarding MicroCoils (and other intracranial coil implants) have been presented in previous 510k submissions to FDA as each new coil family member was introduced. The Cerecyte MicroCoil 18-System is an addition to the Cerecyte 10-System coil line. Below are Bystein 15 an addition equivalence of Cerecyte-18 to the ecomparison tables to and predicate Micrus (10 &18 sized bare platinum helical and spherical) MicroCoil Systems.

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ne Design Comparison Table and Functional Comparison Table Mow the Corecyte-18 Modified MicroColis are designed
identical manner as the current family of CE Marked MicroCoil

DesignFeature	Micrus Platinum 18-System Predicate	Micrus Cerecyte-10 System Predicate	Micrus Cerecyte-18 System
ImplantMaterialComposition	Platinum Tungsten Alloy Wire.No suture.	Platinum Tungsten Alloy Wire.Absorbable PGA suture.	Same as Cerecyte 10 System predicate
Diameter	Implant available in up to 20 mm diameter	Implant available in up to 10 mm diameter	Same as Platinum 18 System predicate
Implantlength	Implant available in up to 30 cm lengths	Implant available in up to 15 cm lengths	Same as Platinum 18 System predicate
DevicePositioningUnit (DPU)	Stainless steel hypotube (proximal), stainless steel braid (mid), and polymer (distal) sheathing for 2 conduction wires and distal resistive heating coil.	Stainless steel hypotube (proximal), stainless steel braid (mid), and polymer (distal) sheathing for 2 conduction wires and distal resistive heating coil.	Same as predicates.
ConnectingCablecompatibility	Single cable with proprietary connectors to fit only the Micrus Detachment Control Box and the Micrus MicroCoil System.	Single cable with proprietary connectors to fit only the Micrus Detachment Control Box and the Micrus MicroCoil System.	Same as predicates.
Detachmenttechnique	Shear polyethylene fiber with a loop of resistively heated coil.	Shear polyethylene fiber with a loop of resistively heated coil.	Same as predicates.
Packaging	Packaged in plastic loop, enclosed in foil pouch	Packaged in plastic loop, enclosed in foil pouch	Packaged in plastic loop, enclosed in foil pouch
Instructionsfor Use	Uses a single IFU for the entire MicroCoil family	Uses a single IFU for the entire MicroCoil family	Same as predicates
Microcathetercompatibility	Compatible with 2-tip marker microcatheters:• 10 system uses 10 & 14 catheters• 18 system uses 14 & 18 catheters	Compatible with 2-tip marker microcatheters:• 10 system uses 10 & 14 catheters	Compatible with 2-tip marker microcatheters:• 18 system uses 14 & 18 catheters
Sterilization	E-Beam	E-Beam	E-Beam

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Functional Testing - Best-Practice Comparison Table

Fuctional Tresting Comparison-Trability as other Missility as other MicroColl
The physician will expect the same level of System to ensure the design change did a
dited with

The following studies were performed specifically on the Cerecyte-18 Microcoil System to ensure the
affect safety or function.
sign

spect safety or function

Functional Comparison Table
Test	Micrus Modified MicroCoil System Test Result	Substantial Equivalence
Coil Stiffness/Softness forCerecyte-18 MicroCoilsV0544	Characteristic: Stiffness limits for the Cerecyte-18 MicroCoil Systems.Test data: The Cerecyte-18 MicroCoils met the stiffness specifications.	Substantially equivalent.
Friction in the Microcatheter(Delivery Force)V0542	Characteristic: Average push force must be substantially equivalentto predicates.Test data: The Modified MicroCoil had average push forces that arecomparable to those of the predicate.	Substantially equivalent.
Tensile StrengthV0547	Characteristic: Pre-detachment tensile strength of the suture ball tip andMicroCoil to DPU must be substantially equivalent to the stretch resistantCerecyte-10 predicate.Test data: Tensile strength meets desired strength criteria.	Substantially equivalentto the stretch resistantpredicate
Durability (Reliability afterFatigue)V0543	Characteristic: Withstand deployment and retraction 6 times in a tortuousanatomy.Test data: No knotting, no breakage, no stretching occurred. Durabilitymeets desired durability criteria.	Substantially equivalent.
Test	Micrus Modified MicroCoil System Test Result	Substantial Equivalence
Sterilization ValidationV0394 for Cerecyte 10-System	Characteristic: Minimum Sterility Assurance Level of 10-6.Test data: Cerecyte-10 was validated under V0394. Due to the significant similarities (in materials used, manufacturing processes, product weight & density, and packaging) between the 10 & 18 Systems, V0394 will serve as validation for the 18-system Cerecyte.	Substantially equivalent.
MRI Compatibility of Implant	No change was made which would impact MRI compatibility.	Substantially equivalent
Package IntegrityV0399 for Cerecyte 10 System	Characteristic: Demonstrate package integrity per ISO 11607Test: No change was made to packaging. Reference Cerecyte 10 test result V0399.	Substantially equivalent
Ship/TransitV0400 for Cerecyte 10 System	Characteristic: Successfully withstand domestic and international distribution environmentTest: Does successfully withstand domestic and international distribution environment. No change was made to packaging or product materials. Reference Cerecyte 10 test result.	Substantially equivalent
This functional testing demonstrates the substantially equivalent performance of the Micrus Cerecyte-18 MicroCoil System with the 2 predicate devices: (1) Micrus MicroCoil Delivery System, and (2) Micrus Cerecyte-10 MicroCoil System. All test results are included in "Section 2.2, Verification/Validation."

Table て .....

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he following studies were performed on the Cerecyte-10 Microcoll System and are lised here as a reference because the f
esults also apply to the Cerecyte 18 Microcoil System

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Summary of Safety and Effectiveness

Based upon the design, materials, function, intended use, comparison with currently Based upon the design, materials, frinal testing performed by Micrus Endovascular marketed devices and the Micrus Modified MicroCoil, "Cerecyte" 18-System Corporation, it is concluded that the Micros Modified MicroCoil "Cerecyte" 10-System in safety and effectiveness.

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Endovascular Corporation November 28, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three wings, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

DEC 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Margaret Webber Director, Regulatory & Clinical Affairs Micrus Endovascular Corporation 610 Palomar Avenue Sunnyvale, California 94085

Re: K053160

Trade/Device Name: Micrus Modified Microcoil 18-System, "Cerecyte" Model #s CSP and CHE Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: November 8, 2005 Received: November 14, 2005

Dear Ms. Webber:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection b r (2) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to tegans and the Medical Device Amendments, or to commerce prior to May 20, 1978, the entordance with the provisions of the Federal Food, Drug. devices that have been receaselied in quire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, market the devices, connements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (500 a0010) inc. Existing major regulations affecting your device can Inay be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Couvecements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast be advised that I Drivedants - rour device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must or any rederal statures and regulations adminding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualify of oversions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Margaret Webber

This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to begin manieans your device of your device to a legally premitset notincation. The PDF miaing of casification 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 II you uestre specific advice for your aconce on our car and the regulation entitled, contact the Office of Compundio at (2 + notification" (21CFR Part 807.97). You may obtain Wisbiraliums by reference to premainter for the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Briem

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K053160
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Indications for Use

510(k) Number (if known): K053160

Device Name: Micrus Modified Microcoil 18-System, Cerecyte" Model #s CSP and CHE

Indications For Use:

The Micrus Modified Microcoil System, "Cerecyte-18" is intended for endovascular embolization of intracranial aneurysms.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare Bueln

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

510(k) Number K053160

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).