The Flipper™ Detachable Embolization Coil is used for arterial and venous embolization for the peripheral vasculature. This device is used in conjunction with the Flipper Detachable Coil Delivery Wire. The detachable coil delivery system provides safe delivery of embolization coils where the size of embolization coil is difficult to predetermine. A handle facilitates manipulation and provides safe and easy detachment of embolization coils. This device is provided sterile and is intended for one-time use.

The Flipper™ Detachable Embolization Coil consists of the embolization coils and the delivery wire. The embolization coils are manufactured using stainless steel wire with synthetic fibers. The delivery wire is manufactured using stainless steel with TFE coating. The device will be available in the following sizes and is compatible with catheters of 80 and 110 cm lengths.

Delivery Wire Diameter: 0.035"
Extended Embolus Diameter: 0.035"
Coil Length: 3cm, 4cm, 5cm, 6cm, 8cm, 10cm, 12cm
Coil Embolus Diameter: 3mm, 5mm, 6.5mm, 8mm

AI/ML Overview

The provided document describes a medical device, the Flipper™ Detachable Embolization Coil, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a typical AI/software device would.

This document is a 510(k) premarket notification for a traditional medical device (an embolization coil). For such devices, "acceptance criteria" and "performance studies" are typically related to engineering and material testing, not statistical performance metrics like sensitivity, specificity, or reader agreement that are common for AI/software devices.

Here's an analysis based on the provided text, indicating what information is present and what is notably absent for an AI-focused request:

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

Acceptance Criteria: Not explicitly stated in the format expected for a statistical performance study (e.g., "sensitivity must be > X%"). The document refers to "requirements of the design plan" but doesn't detail these as specific, quantifiable acceptance criteria for clinical performance.
Reported Device Performance: The document lists "Performance Data" as:
- In-Vitro Performance Test: Loading, Passage and Deployment
- Tensile Test: Coil Thread/Delivery System
- Tensile Test: Torque Wire to Braid Solder
- Performance Results: The document generally states, "The results of these tests provide reasonable at the device has been designed and tested to assure conformance to the requirer to its use for arterial and venous embolization in the peripheral vasculature." However, no specific numerical results or metrics of these tests are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: The document does not describe a clinical test set in the context of diagnostic or AI performance evaluation. The "tests" mentioned are in-vitro performance and tensile tests, which would apply to the device components themselves, not to patient data. Therefore, concepts like data provenance or retrospective/prospective studies do not apply here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: There is no mention of human experts establishing ground truth, as the document concerns the mechanical and functional aspects of an embolization coil, not the interpretation of medical images or data.

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

Not Applicable / Not Provided: No adjudication method is mentioned, as there is no human interpretation or expert panel involved in the described testing.

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 / Not Provided: No MRMC study was conducted. This device is an embolization coil, not an AI diagnostic tool.

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

Not Applicable / Not Provided: This question is for AI algorithms. The device is a physical medical implant.

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

Not Applicable / Not Provided: The ground truth for the "Performance Data" cited would relate to engineering specifications (e.g., coil integrity under tension, successful deployment in an in-vitro model) rather than clinical "ground truth" derived from patient outcomes or expert pathological review. The document does not specify how conformance to design requirements was definitively "ground-truthed."

8. The sample size for the training set

Not Applicable / Not Provided: Training sets are relevant for AI/machine learning models. This document describes a physical medical device.

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

Not Applicable / Not Provided: As above, this is not relevant to the described device.

In summary: The provided 510(k) notification focuses on demonstrating "substantial equivalence" of a mechanical embolization coil to existing predicate devices based on design, materials, intended use, and general performance testing (in-vitro and tensile). It does not present information relevant to the statistical performance evaluation criteria or study design typically associated with AI/software devices as outlined in your request.

Summary

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JAN 1 1 2000

K993455

178

Safety and Effectiveness Information

Submitted By:	Karen Bradburn
	Regulatory Affairs Coordinator
	COOK INCORPORATED
	925 South Curry Pike
	P.O. Box 489
	Bloomington, IN 47402
	(812) 339-2235

Device:

Flipper™ Detachable Embolization Coil Device, Embolization, Arterial (79KRD) 21 C.F.R. Part 870.3300

Predicate Devices

The Flipper™ Detachable Embolization C s of intended use, materials of construction and technological charact edicate devices reviewed: Embolization Coil Positioner Set, Hilal Embolization Vascular Occlusion System, Guglielmi Detachable Coil and Fibered Platinuit

Device Description

Delivery Wire Diameter	0.035"
Extended Embolus Diameter	0.035"
Coil Length	3cm, 4cm, 5cm, 6cm, 8cm, 10cm,12cm
Coil Embolus Diameter	3mm, 5mm, 6.5mm, 8mm

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Substantial Equivalence

The Flipper™ Detachable Embolization Coil is similar to many devices already in commercial distribution for arterial and venous embolization. These devices include an Embolization Coil Positioner Set (Cook Incorporated), Hilal Embolization Microcoils (Cook Incorporated), the Vascular Occlusion System (Cordis Endovascular Systems 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 D.C. K940189 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 bstantially equivalent under D.C. K901337 and are indicated for the embolization of tiovenous malformations and other vascular lesions of the brain, spinal cord and spine. The is constructed of platinum and synthetic fiber with a coil wire diameter of 0.018 in theses. 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 Vascular Occlusion System was reviewed as substantially equivalent under D.C. K983483 and may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. It is intended for the interventional radiologic management of arteriovenous malformation, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord and spine. The device is constructed of platinum and synthetic fiber with a coil wire diameter of 0.014 inches. The coils are available in straight. "C", flat spiral and complex shapes with an emboli size range of 2 to 10 mm. Deployment is achieved by a wire guide which pushes the coils out of the microcatheter.

The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256. K960705 and K962503 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 coils are deployed by electrolytic detachment from the wire guide.

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

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The Flipper™ Detachable Embolization Coil will be indicated for arterial and venous embolization for the peripheral vasculature. The delivery wire will be constructed of stainless steel with a diameter of 0.035 inches. The stainless steel coils with synthetic fiber will be available in curled shapes with an coil embolus diameter range of 3 to 8 mm. The coil is deployed when interlocking threads between the coils and the delivery wire are unscrewed.

Performance Data

The following tests have been performed to evaluate the ability of the Flipper Detachable Embolization Coil to perform in accordance with the requirements of the design plan.

In-Vitro Performance Test: Loading, Passage and Deployment
Tensile Test: Coil Thread/Delivery System.

- Tensile Test: Torque Wire to Braid Solder
  The results of these tests provide reasonable at the device has been designed and tested to assure conformance to the requirer to its use for arterial and venous embolization in the peripheral vasculature.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest the head and wings.

JAN 1 1 2000

Ms. Karen Bradburn Regulatory Affairs Coordinator Cook, Inc. P.O. Box 489 Bloomington, In 47402

Re: K993455 Flipper™ Detachable Embolization Coil Regulatory Class: III Product Code: KRD Dated: October 12, 1999 Received: October 13, 1999

Dear Ms. Bradburn:

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 general controls provisions of the Act include the Act. 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket 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 continue marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 - Ms. Karen Bradburn

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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Acting Director Division of Cardiovascular Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Premarket Notification Flipper™ Detachable Embolization Coil COOK INCORPORATED

510(k) Number (if known):	K 993455
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Flipper™ Detachable Embolization Coil Device Name:

Used for arterial and venous embolization in the peripheral vasculature. Indications for Use:

Bree R. Campbell

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 99345 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Division Sign 1111 Division of .. manager a spillators and Neurolog Compar 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).