This document is a 510(k) summary for the Micrus Cashmere-14 Microcoil System. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study of device performance against acceptance criteria in the typical sense of a clinical trial for an AI/ML device.

Therefore, many of the requested categories are not applicable to this type of regulatory submission for a medical device that is not an AI/ML product.

Here's a breakdown of the information that is available or applicable from the provided text, and an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not present because this is a 510(k) submission focused on substantial equivalence to existing predicate devices, rather than meeting novel performance acceptance criteria through a standalone study. The "performance" described is the device's design, material, function, and manufacturing being equivalent to predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (as per submission)
Intended Use equivalent to predicate devices	Equivalent: Intended for endovascular embolization of intracranial aneurysms.
Design equivalent to predicate devices	Equivalent: Shares design characteristics.
Material of construction equivalent to predicate devices	Equivalent: Uses same method and material of construction as predicate (Micrus SR Helical-18 Microcoil System). Equivalent to Boston Scientific GDC 360 and Cordis Orbit microcoil predicates.
Implant dimensions (wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, coil length) equivalent to predicate devices	Equivalent: Same dimensions as predicate (Micrus SR Helical-18 Microcoil System). Equivalent to Boston Scientific GDC 360 and Cordis Orbit microcoil predicates.
Manufacturing method equivalent to predicate devices	Equivalent: Uses same method as predicate (Micrus SR Helical-18 Microcoil System).
Packaging equivalent to predicate devices	Equivalent: Uses same packaging as predicate (Micrus SR Helical-18 Microcoil System).
Sterilization method equivalent to predicate devices	Equivalent: Uses same sterilization method as predicate (Micrus SR Helical-18 Microcoil System).
No alteration to fundamental technology of predicate device	Confirmed: "The modification has not altered the fundamental technology of the sponsor's predicate device."
Safety and Effectiveness substantially equivalent to predicate devices	Concluded: "It is concluded that the Micrus Cashmere-14 Microcoil System is substantially equivalent to the predicate devices in safety and effectiveness."

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

Not Applicable: This document does not describe a clinical study or a "test set" of patient data in the context of an AI/ML device or novel performance criteria. The evaluation is based on non-clinical testing (likely bench testing, material testing, and design comparisons) and comparison to predicate devices, not data from a test set of patient cases.

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

Not Applicable: There is no "test set" of patient cases for which ground truth would be established by experts. The evaluation focuses on engineering and material equivalence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable: No clinical test set.

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

Not Applicable: This device is a physical medical implant (a microcoil), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not Applicable: This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable: For a 510(k) submission showing substantial equivalence of a physical device, the "ground truth" is typically the established safety and effectiveness of the predicate device(s) and demonstrable equivalence in design, materials, and function through engineering tests and analyses, rather than clinical outcomes or pathology data for a new device.

8. The sample size for the training set

Not Applicable: This is not an AI/ML device requiring a training set.

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

Not Applicable: This is not an AI/ML device requiring a training set.

Summary of the document's content:

The document is a 510(k) Premarket Notification for the Micrus Cashmere-14 Microcoil System. It asserts that the device is substantially equivalent to several predicate devices (Micrus SR Helical-18 Microcoil System, Boston Scientific GDC 360, Cordis Trufill DCS Orbit Detachable Coil) in terms of:

Intended Use: Endovascular embolization of intracranial aneurysms.
Design: Including implant dimensions (wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, coil length).
Material of Construction: Same method and material.
Manufacturing Method.
Packaging.
Sterilization Method.

The conclusion is based on design, materials, function, intended use, and non-clinical testing performed by Micrus Endovascular Corporation, leading to the determination of substantial equivalence in safety and effectiveness. The FDA concurred with this determination, allowing the device to be marketed.

Summary

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1.4 Summary of Safety and Effectiveness

Submitter Name andAddress:	Micrus Endovascular Corp.821 Fox LaneSan Jose, CA 95131		JAN 17 2007
Contact Name:	Patrick Lee, Regulatory Affairs SpecialistPhone: 408-433-1428Fax: 408-433-1401Email: plee@micruscorp.com
Preparation Date:	December 5, 2006
Device Name andClassification:	Micrus Microcoil System "Cashmere"Common Name: Micrus Microcoil System "Cashmere"Classification Name: Device, Artificial Embolization
	Regulatory Class II
Predicate Devices:	Micrus Stretch-Resistant Microcoil, 510(k) no.K022420Micrus Microcoil Delivery System, 510(k) no. K002056Boston Scientific GDC 360 Soft SR, 510(k) no. K042539Cordis Trufill DCS Orbit Detachable Coil, 510(k) no.K032553
Device Description:	The Micrus Cashmere-14 MicroCoil System consists of anembolic coil ("MicroCoil") attached to a Device PositioningUnit (DPU) (single use, sterile).
Device Intended Use	The Micrus MicroCoil Delivery System is intended forendovascular embolization of intracranial aneurysms.

Comparison to Predicate Devices:

The Micrus Cashmere-14 Microcoil Systems have shown substantial equivalence to the Micrus SR Helical-18 Microcoil System in terms of intended use, design, material of construction, implant dimensions including wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, and coil length. The Cashmere-14 Microcoil system uses the same method and material of construction, packaging, and sterilization method as its predicate. The modification has not altered the fundamental technology of the sponsor's predicate device

The Micrus Cashmere-14 Microcoil System have also shown substantial equivalence to the Boston Scientific GDC 360 and Cordis Orbit microcoil predicates in terms of

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intended use and design, material of construction, implant dimensions including wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, and coil length.

Conclusion:

Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Cashmere-14 Microcoil System is substantially equivalent to the predicate devices in safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Micrus Endovascular Corp. % Mr. Patrick Lee Regulatory Affairs Specialist 821 Fox Lane San Jose, California 95131

JAN 1 7 2007

Re: K063653

Trade/Device Name: Cashmere-14 MicroCoil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: December 6, 2006 Received: December 8, 2006

Dear Mr. Lee:

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 - Mr. Patrick Lee

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 (240) 276-0115 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K06361$\overline{3}$

Indications for Use

510(k) Number (if known): _

Micrus Microcoil System . "Cashmere" Device Name: _______________

Model #: SRC140512-20, SRC140615-20, SRC140717-20, SRC140820-20,

SRC140922-20, SRC141025-20, SRC141127-20, SRC141230-20

Indications For Use:

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

Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D)

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)

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

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510(k) Number

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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).