Hilal Embolization MicroCoils™ are manufactured from coiled platinum wire with equidistantly spaced nylon fibers and are available in straight, single-curl, and multiplecurl configurations. The Hilal coils are designed to be delivered by microcatheters with a minimum end hole diameter of 0.018 inch. The extended embolus lengths of the finished device range from 0.5 to 6.0 centimeters. The coiled embolus diameters range from 2 to 10 millimeters. The Hilal coils are loaded in a straight configuration into a loading cartridge. A loading stylet is also provided for loading this coil into the delivery catheter.

AI/ML Overview

The provided text describes the Hilal Embolization MicroCoils™ and its substantial equivalence to a predicate device, the Cook Retracta® Detachable Embolization Coil. The information required for a detailed study description is somewhat limited in this document, as it summarizes performance data rather than providing a full study report.

Based on the available text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Wire Tensile Testing: Peak load value greater than or equal to minimum tensile strength requirements.	The predetermined acceptance criteria were met.
Animal Testing (Acute Performance): No evidence of arterial damage or coil migration in a porcine model.	The predetermined acceptance criteria were met (for straight and single curl Hilal coils).

Note: For "Coil Tensile Testing," the document only states that testing characterized the uniaxial tensile strength, but does not explicitly mention acceptance criteria or if it was met.

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

Wire Tensile Testing: Not specified.
Coil Tensile Testing: Not specified.
Animal Testing: Not specified, but performed using a "porcine model." The provenance is a laboratory setting.
Leveraged Testing (Nester® and Tornado® Embolization Coils): Sample sizes for bench, MRI, and animal testing are not specified.

The data provenance is likely prospective for the tests performed directly on the Hilal Embolization MicroCoils™ as it's part of a premarket notification to establish substantial equivalence.

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

This information is not provided in the document. The animal testing results would likely be evaluated by veterinary or medical experts, but their number and qualifications are not disclosed.

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

This information is not provided in the document.

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 is not applicable. The device is an embolization microcoil, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

Wire Tensile Testing & Coil Tensile Testing: Mechanical measurements against engineering specifications.
Animal Testing: Outcomes data based on direct observation of arterial damage or coil migration in a porcine model. This would be observed and assessed by researchers/veterinarians.

8. The sample size for the training set:

There is no training set mentioned for this device. The tests described are performance verification tests. The device is a physical medical device, not an algorithm that requires a training set.

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

As there is no training set, this question is not applicable.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 3, 2016

Cook Incorporated Mr. David Lehr Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K160219

Trade/Device Name: Hilal Embolization MicroCoils™ Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: June 23, 2016 Received: June 24, 2016

Dear Mr. David Lehr:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours

sincerely yours,

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160219

Device Name Hilal Embolization MicroCoils™

Indications for Use (Describe)

The Hilal Embolization MicroCoils™ are intended for arterial and venous embolization in the peripheral vasculature.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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2.0 510(k) SUMMARY

As required by 21 CFR §807.92 Date Prepared: August 1, 2016

I. SUBMITTER

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Contact:	David Lehr, RAC
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 ext. 102309
Contact Fax Number:	(812) 332-0281

II. DEVICE

Trade Name:	Hilal Embolization MicroCoilsTM
Common Name:	Vascular Embolization Device
Classification Name:	Device, Vascular, For Promoting Embolization
Regulation/Class:	21 CFR §870.3300/Class II
Product Code	KRD

III. PREDICATE DEVICE

The device subject of this submission is considered substantially equivalent to the predicate device, the Cook Retracta® Detachable Embolization Coil (K123712/K151676), which has never been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Hilal Embolization MicroCoils™ are intended for arterial and venous embolization in the peripheral vasculature.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device, the Hilal Embolization MicroCoils™, and the predicate device, the Retracta® Detachable Embolization Coil (K123712/151676), are substantially equivalent in that these devices have identical intended uses and similar technological characteristics. The predicate device is a combined embolization coil and delivery wire. Its embolization coil (made of platinum wire and nylon fibers) is delivered by a detachment mechanism. The subject device is a pushable embolization coil (also made of platinum wire and nylon fibers) delivered with a wire guide through a delivery catheter. The predicate coils (intended for delivery through catheters with an end hole size of 0.035 inch) have a helical shape and are available in lengths of 7 cm or 14 cm and diameters ranging from 4 to 20 mm. The subject Hilal coils (intended for delivery through catheters with end hole sizes of 0.018 through 0.025 inch) have straight, singlecurl, and multiple-curl shapes and are available in lengths ranging from 0.5 to 6 cm and in diameters ranging from 2 to 10 mm. Additionally, the subject device, like the predicate device, is labeled as MR Conditional. However, there are differences in the MR scanning conditions to reflect the testing performed on the subject device. Based on the comparison of the design, intended use, materials, fundamental technology, and principle of operation, the subject device is considered to be substantially equivalent to the currently marketed predicate device.

VII. PERFORMANCE DATA

The subject device underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters.

. Wire Tensile Testing - Testing shows the raw wire has a peak load value greater than or equal to the minimum tensile strength requirements. The predetermined acceptance criteria were met.
Coil Tensile Testing - Testing characterized the embolization coils' uniaxial tensile strength.
. Animal Testing – An acute performance study was performed in a porcine model on straight and single curl Hilal coils, showing no evidence of arterial damage or coil migration. The predetermined acceptance criteria were met.

K160219

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Cook Incorporated - Traditional 510(k) Hilal Embolization MicroCoilsTM August 1, 2016

Other testing was leveraged from the 510(k) submission for Nester® and Tornado® Embolization Coils (K153778). Performance (bench, MRI, and animal) and biocompatibility testing was conducted in accordance with applicable FDA guidance documents to confirm the reliable performance of critical device characteristics.

VIII. CONCLUSIONS

The data included in this submission indicate that the subject device does not raise new questions of safety or effectiveness compared to the predicate device. This supports a determination of substantial equivalence.

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).