This embolization coil system is supplied sterile and is intended for one time use. The device is comprised of an introducer system with a premounted detachable embolization coil. The embolization coil is deployed when the interlocking threads between the coil and the delivery wire are "unscrewed" by turning the delivery wire counterclockwise approximately 25 times.

The introducer system consists of a delivery wire and a delivery wire inserter. The delivery wire inserter consists of a plastic delivery wire holder with the delivery wire and a cannula inserter containing the coil. A Detach Locking Device is also needed to use the set. This part is sold separately because several coils can be delivered through one Detach Locking Device. These components are further described below.

Coil: The coil is constructed of platinum and is available in the following shapes: curled, straight, Tornado™, J-Coil Shape and Multiple J-Coil Shape. The coil is also available in three degrees of softness: Detach 18® standard, Detach 18® soft, and Detach 110.
Delivery Wire: The delivery wire is comprised of four components: a handle, the delivery wire, a marker band and a detach tip. These are constructed of platinum and PTFE coated stainless steel. The delivery wires for Detach 11® and Detach 18® are available in a length of 200 cm. The diameter of the Detach 11@ delivery wire is 0.011 inches. The diameter of the Detach 18® delivery wire is 0.018 inches.
Delivery Wire Inserter: The delivery wire inserter is also comprised of four components. These include a stainless steel tip, a polycarbonate tip fitting, polyethylene tubing and a nylon fitting.
Detach Locking Device: The Detach Locking Device is basically a pin vise which ensures that the delivery wire does not move forward during coil detachment. This device does not contact the skin or the blood.

AI/ML Overview

The Embolization Coil System (Detach 11® and Detach 18®) was evaluated for safety and effectiveness through a series of tests. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria with numerical targets. However, the tests performed serve to assure reliable design and performance, and successful completion of these tests implies that the device meets the implied acceptance criteria for its intended use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Integrity (Tensile Strength)	Tensile Tests: Performed on Detach 18®, Detach 11®, and Detachable Coils. (Results are not quantified in the provided text but implied to be successful as they "assure reliable design and performance").
Deployment and Functionality in a Controlled Environment	Performance Test in a Microferret™ Catheter Mounted in a Phantom: Conducted to evaluate deployment and functionality. (Results are not quantified but implied to be successful as they "assure reliable design and performance").
Material Biocompatibility and Sterility	Sterile and Intended for One Time Use: Device is supplied sterile, implying it meets sterility standards. Materials (platinum, PTFE coated stainless steel, polycarbonate, polyethylene, nylon) are common in medical devices, implying biocompatibility was considered and met. (No specific biocompatibility or sterility test results are provided, but these are standard expectations for such devices).
Dimensional Specifications	Coil Wire Diameter: Detach 11® (0.011 inches), Detach 18® (0.018 inches). Proposed device: 0.011, 0.014, and 0.018 inches. Emboli Size Range: Detach 11®/18® (2 to 12 mm). Delivery wire length: 200 cm. (Implied that these dimensions meet the design specifications for safe and effective use within the target vasculature).
Deployment Mechanism Functionality	The coil is deployed when interlocking threads between the coil and the delivery wire are "unscrewed" by turning the delivery wire counterclockwise approximately 25 times. The Detach Locking Device ensures the delivery wire does not move forward during detachment. (Implied that this mechanism functions reliably as designed).

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

The document does not specify the exact sample sizes used for each test (Tensile tests, Performance Test). It simply states that Detach 11®/18® "was subjected to the following tests."

Test Set Sample Size: Not specified.
Data Provenance: The tests were conducted internally by COOK INCORPORATED ("COOK INCORPORATED was subjected to the following tests"). The country of origin of the data is therefore likely the USA, where Cook Incorporated is based. The nature of the tests (tensile tests, phantom performance tests) indicates they are prospective experimental tests conducted on the device prototypes or production samples.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

It is common for such internal engineering tests to be evaluated by qualified engineers and technical personnel within the company, but specific details are not provided in this regulatory submission.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

For the types of mechanical and performance tests described, "adjudication" in the sense of a consensus among multiple human reviewers for subjective outcomes is not typically applicable. The results are usually quantitative (e.g., force measurements for tensile tests) or observable functional outcomes (e.g., successful deployment in a phantom). The interpretation of these results against predefined engineering specifications would be handled by the testing personnel.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done.

This submission is for a medical device (embolization coil), not an AI or imaging diagnostic tool. MRMC studies are primarily relevant for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers interpret medical images.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

Standalone Performance Study: No, a standalone performance study was not done, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the specific tests mentioned:

Tensile Tests: The "ground truth" would be established by predefined engineering specifications for strength and durability. The device's performance (e.g., ultimate tensile strength, elongation at break) would be measured and compared against these specifications.
Performance Test in a Microferret™ Catheter Mounted in a Phantom: The "ground truth" would be the successful, unhindered deployment and detachment of the coil within the simulated anatomy. This is a functional assessment against expected operational parameters.

In essence, the ground truth is based on engineering specifications and functional performance criteria for the device.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable.

This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. Design and development are based on engineering principles and iterative testing, not by training a model on data.

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

Ground Truth for Training Set: Not applicable.

As mentioned above, there is no training set for this type of device. The design specifications and performance requirements that guide the device's development are established through engineering analysis, clinical needs assessment, and regulatory standards.

Summary

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DEC 2 0 1999

131
K992121

510(k) Premarket Notification Embolization Coil System COOK INCORPORATED

Safety and Effectiveness Information

Submitted By: Lisa Webb, RAC Regulatory Affairs Coordinator COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 June 21, 1999

Device:	Trade Name:	Detach 11® and Detach
---------	-------------	-----------------------

Proposed Classification Name:

188

Arterial Embolization Device

Predicate Devices:

Detach 11@/18® is similar in terms of intended use, materials of construction and technological characteristics to the predicate devices reviewed, the Embolization Coil Positioner Set, Hilal Embolization Microcoils™, the Guglielmi Detachable Coil® and the Fibered Platinum Coil.

Device Description

Coil: The coil is constructed of platinum and is available in the following shapes: curled, straight, Tornado™, J-Coil Shape and Multiple J-Coil Shape. The coil is also available in three degrees of softness: Detach 18® standard, Detach 18® soft, and Detach 110.
Delivery Wire: The delivery wire is comprised of four components: a handle, the delivery wire, a marker band and a detach tip. These are constructed of platinum and PTFE coated stainless steel. The delivery wires for Detach 11® and Detach 18® are available in a

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length of 200 cm. The diameter of the Detach 11@ delivery wire is 0.011 inches. The diameter of the Detach 18® delivery wire is 0.018 inches.

트 Delivery Wire Inserter: The delivery wire inserter is also comprised of four components. These include a stainless steel tip, a polycarbonate tip fitting, polyethylene tubing and a nylon fitting.
트 Detach Locking Device: The Detach Locking Device is basically a pin vise which ensures that the delivery wire does not move forward during coil detachment. This device does not contact the skin or the blood.

Substantial Equivalence

Four devices are currently marketed in the U.S. which are believed to be substantially equivalent to Detach 11@/18@. These devices include an Embolization Coil Positioner Set (COOK INC), Hilal Embolization Microcoils™ (COOK INC), the Guglielmi Detachable Coil® (Target Therapeutics®) and a Fibered Platinum Coil (Target Therapeutics®). All devices are introduced via the percutaneous method of entry using a catheter or microcatheter introducer.

The Embolization Coil Positioner Set was reviewed as substantially equivalent under K942189 and is indicated for arterial and venous embolization. The device is constructed of stainless steel and synthetic fiber with a coil wire diameter of 0.018 to 0.038 inches. The coils are available in straight or curled shapes with an emboli size range of 2 to 20 mm. A push-button release mechanism is the method of deployment.

Hilal Embolization Microcoils™ were reviewed as substantially equivalent under K901337 and are indicated for the embolization of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine. The device is constructed of platinum coil and synthetic fiber with a coil wire diameter of 0.018 inches. The coils are available in straight and curled shapes with an emboli size range of 3 to 10 mm. Deployment is achieved by a wire guide which pushes the coil out of the catheter.

The Guglielmi Detachable Coil® was reviewed as substantially equivalent under K951256 and K960705 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae and arterial venous embolizations in the peripheral vasculature. The device is constructed of platinum with a coil wire diameter of 0.010 to 0.018 inches. The coils are available in a helical shape with an emboli size range of 2 to 20 mm. The coil is deployed by electrolytic detachment from the wire guide.

The Fibered Platinum Coil was reviewed as substantially equivalent under K955293 and is indicated for arterial and venous embolization in the peripheral vasculature. The device is

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510(k) Premarket Notification Embolization Coil System COOK INCORPORATED

constructed of platinum and synthetic fiber with a coil wire diameter of 0.010 to 0.035 inches. The coils are available in the following shapes: straight, C-shaped, helical and complex helical. The emboli size range is 2 to 30 mm. Deployment is achieved by a wire guide which pushes the coil out of the catheter.

The Detach 11@/18® will be indicated for arterial and venous embolization. This device will be constructed of platinum with a coil wire diameter of 0.011, 0.014 and 0.018 inches. The coils will be available in curled, straight, Tornado™, J-coil and multiple J-coil shapes. The emboli size range will be 2 to 12 mm. The coil is deployed when interlocking threads between the coil and the delivery wire are "unscrewed."

The similar indications for use and technological characteristics of the Detach 11® and Detach 18® Embolization Coil Systems as compared to the predicate devices support a determination of substantial equivalency.

Test Data

Detach 11@/18® was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

� Tensile tests: Detach 188
� Tensile tests: Detach 11®
� Tensile tests: Detachable Coils
� Performance Test in a Microferret™ Catheter Mounted in a Phantom

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use for arterial and venous embolization.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus with a human figure in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEC 20 1999

Ms. Lisa Webb Regulatory Affairs Coordinator Cook Incorporated 925 South Cury Pike P.O. Box 489 Bloomington, IN 47402

K992121 Re: Embolization Coil System Requlatory Class: III (Three) Product Code: KRD September 23, 1999 Dated: Received: September 24, 1999

Dear Ms. Webb:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Ms. Lisa Webb

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

S/Kute L. Campbell

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Addendum to K992121 510(k) Premarket Notification Embolization Coil System COOK INCORPORATED

510(k) Number (if known): K992121

Device Name:

Embolization Coil System

Indications for Use:

Arterial and venous embolization in the peripheral vasculature

Bess L. Leasure

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number __ Kggaj 2

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

い Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

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).