The Flipper® Detachable Embolization Coil (Inconel) is used for arterial and venous embolization procedures in the peripheral vasculature. The device is supplied sterile and intended for one-time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has a coil wire diameter of 0.035 inches. It is available in a curled shape. The emboli size range is 3 to 8 mm. The embolization coil includes synthetic fibers evenly placed down the length of the coil. The device is introduced to the target vessel using an angiographic catheter (sold separately) and deployment is achieved when the threads between the coil and the Flipper® Detachable Coil Delivery Wire are unscrewed.

AI/ML Overview

The acceptance criteria and study detailed in the provided text for the Flipper Detachable Embolization Coil (Inconel) are focused on the device's physical performance characteristics rather than diagnostic accuracy or human-in-the-loop performance. Therefore, many of the requested fields related to AI/ML or diagnostic performance studies cannot be fully addressed.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Coil Deformation Testing	Meets applicable requirements
Wire Tensile Strength	Meets applicable requirements
Delivery Friction Testing	Meets applicable requirements
Fiber Pull-Out Testing	Meets applicable requirements
Detachment Reliability Testing	Meets applicable requirements
Magnetic Resonance (MR) Testing	Meets applicable requirements

Note: The document states "Testing data are presented to demonstrate that the Flipper® Detachable Embolization Coil (Inconel) meets applicable design and performance requirements." but does not provide specific quantitative acceptance limits or detailed test results within this summary.

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

The document does not specify the sample sizes (number of coils/tests) used for each of the performance tests. The data provenance is Cook Incorporated's internal testing. The tests are "retrospective" in the sense that they were performed on manufactured devices prior to submission for clearance, but not in the context of analyzing existing clinical data.

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

Not applicable. The "ground truth" for these performance tests is determined by engineering specifications and objective measurements, not expert consensus as would be typical for diagnostic devices.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined engineering standards, not subjective assessments requiring adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an embolization coil, and the provided documentation focuses on its physical and functional performance, not diagnostic imaging or human interpretation.

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

No, a standalone (algorithm only) performance study was not done. This is a medical device (embolization coil), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., Coil Deformation, Wire Tensile Strength) would be defined by the pre-established engineering specifications and physical characteristics of the device deemed safe and effective for its intended use. This is based on engineering specifications and objective physical measurements, not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm, so there is no training set.

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

Not applicable. This device is not an AI/ML algorithm, so there is no training set or ground truth to establish for it.

Summary

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Special 510(k): Device Modification Flipper Detachable Embolization Coils (Inconel) COOK INCORPORATED 04 December 2006

KO63619 2. Lot2

510(k) SUMMARY

Submitted By:	Lisa Webb, MBA, RACRegulatory Affairs ManagerCook Incorporated750 Daniels Way, P.O. Box 489Bloomington, IN 47402(812) 339-2235 x 2643December 4, 2006
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DEC 2 0 2006

Device:

Trade Name:	Flipper® Detachable Embolization Coil (Inconel)
Proposed Classification Name:	Device, Vascular, Embolization21 CFR 870.3300, KRD
Indications for Use:	Used for arterial and venous embolization in the peripheralvasculature.

Predicate Devices:

The Flipper® Detachable Embolization Coil (Inconel) is similar in terms of intended use, materials of construction, and technological characteristics to the predicate Flipper® Detachable Embolization Coil (stainless steel) and MReye® Embolization Coil.

Device Description:

Substantial Equivalence:

Cook Incorporated currently markets the Flipper® Detachable Embolization Coil (stainless steel—K993455) and the MReye® Embolization Coil (K052834), to which the Flipper® Detachable Embolization Coil (Inconel) is substantially equivalent. The similar indications for use, materials of construction, and technological characteristics of the Flipper® Detachable Embolization Coil (Inconel) as compared to the predicate devices support a determination of substantial equivalence.

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Special 510(k): Device Modification Flipper® Detachable Embolization Coils (Inconel) COOK INCORPORATED 04 December 2006

-063619

Test Data:

Testing data are presented to demonstrate that the Flipper® Detachable Embolization Coil . (Inconel) meets applicable design and performance requirements.

Coil Deformation Testing ■
Wire Tensile Strength 트
Delivery Friction Testing 트
피 Fiber Pull-Out Testing
Detachment Reliability Testing
Magnetic Resonance (MR) Testing ■

The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine, and its presence in the logo signifies the department's role in promoting and protecting the health of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2006

Cook, Incorporated c/o Lisa Webb, MBA, RAC Regulatory Affairs Manager P.O. Box 489 Bloomington, IN 47402-0489

Re: K063619

Trade/Device Name: Flipper® Detachable Embolization Coil Regulation Number: 21 CFR 870.3300 Regulation Name: Embolectomy Coil Regulatory Class: II (two) Product Code: KRD Dated: December 4, 2006 Received: December 5, 2006

Dear Ms. Webb:

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, 7 rug, 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, UDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Webb

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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). 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,

Blymmimor 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):	K063619
Device Name:	Flipper ® Detachable Embolization Coil (Inconel)
Indications for Use:	Used for arterial and venous embolization in the peripheralvasculature.

Prescription Use _ XX (Per 21 CFR 801.109)

OR Over-the-Counter Use

(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 Cardiovascular Devices (a561) 510(k) Number

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).