The Cordis Endovascular Systems, Inc. Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

Device Description

The Vascular Occlusion System consists of straight and shaped TRUFILL Pushable Coils (made from platinum allow and synthetic fibers) and the TRUPUSH Coil Pusher (with 1 or 2 radiopaque markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" inner diameter.

AI/ML Overview

This document, K983483, is a 510(k) premarket notification for the Cordis Endovascular Systems, Inc. Vascular Occlusion System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not applicable or not provided in this type of regulatory document. 510(k) submissions primarily rely on comparison to previously cleared devices.

Here's a breakdown of what is and is not present based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility	All applicable biocompatibility testing was successfully performed for the Vascular Occlusion System. (Implied acceptance criterion is successful performance)
Substantial Equivalence	The Vascular Occlusion System is substantially equivalent in design, materials, sterilization, and indications for use as other commercially available occlusion devices, specifically: - Hilal Embolization Microcoil (Cook, Inc., K901337) - Helix Shaped Coils with Dacron Fibers (Target Therapeutics, K901721) - Vascular Occlusion System (Cordis Endovascular Systems, Inc., K964367, K972881) (The core acceptance criterion for a 510(k) is demonstrating substantial equivalence.)
Performance Standards	The FDA has not established performance standards under Section 514 of the Food, Drug and Cosmetic Act for this device type. (No specific performance acceptance criteria are mentioned beyond biocompatibility and equivalence).

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

Not applicable / Not provided. This document does not describe a clinical or performance study with a "test set" in the context of an algorithm or device performance study. The "testing" referred to is biocompatibility, which typically involves laboratory assays, not human subject data sets in the way implied by the question. The substantial equivalence argument relies on comparison to existing devices, not a new performance study.

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

Not applicable / Not provided. As no "test set" for performance evaluation is described, there's no mention of experts establishing ground truth for such a set.
- The "experts" involved are the FDA reviewers and the manufacturer's regulatory affairs personnel.

4. Adjudication Method for the Test Set:

Not applicable / Not provided. No test set requiring adjudication in the context of performance metrics is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not done or described in this 510(k) premarket notification. These studies are typically for evaluating the impact of AI on human reader performance, which is not the focus of this device (a physical embolization coil system).

6. Standalone (Algorithm Only) Performance Study:

No. This is a physical medical device (embolization coils), not an algorithm or software device. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

Not applicable / Not provided directly. For biocompatibility, the "ground truth" would be the established safety profiles and recognized standards for biological compatibility. For substantial equivalence, the "ground truth" is the established regulatory clearance and safety/effectiveness of the predicate devices. There's no clinical "ground truth" (e.g., pathology, outcomes data) presented from a de novo study.

8. Sample Size for the Training Set:

Not applicable / Not provided. This is not an AI/ML device where a "training set" would be used.

9. How the Ground Truth for the Training Set Was Established:

Not applicable / Not provided. As this is not an AI/ML device, there's no training set or ground truth establishment for such a set.

In summary: This 510(k) submission primarily focuses on demonstrating that the "Vascular Occlusion System" is "substantially equivalent" to predicate devices already on the market, as opposed to presenting novel clinical study data against defined acceptance criteria. The only performance detail provided is the successful completion of biocompatibility testing.

Summary

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K983483
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Appendix A - Summary of Safety and Effectiveness, Continued

General Provisions

The common names used for this device include: .
Platinum Fibered Coils .
- Microcoils or Minicoils .
- The Vascular Occlusion System consists of the following components: .
- TRUFILL Pushable Coils .
- TRUPUSH Coil Pusher .

Predicate Devices

The predicate devices are listed in the table below:

Devices

Device	Manufacturer	510(k) Number,Concurrence Date	Product Code
Hilal EmbolizationMicrocoil	Cook, Inc.	K901337, 11/9/90	HCG
Helix Shaped Coilswith Dacron Fibers	Target Therapeutics	K901721, 1/8/91	HCG
Vascular OcclusionSystem	Cordis EndovascularSystems, Inc.	K964367, 1/30/97K972881, 6/4/98	HCG

Classification Class II

Performance The FDA under Section 514 of the Food, Drug and Cosmetic Act has not Standard established performance standards.

Intended Use The Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

Device The Vascular Occlusion System consists of straight and shaped TRUFILL Description Pushable Coils (made from platinum allow and synthetic fibers) and the TRUPUSH Coil Pusher (with 1 or 2 radiopaque markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" inner diameter.

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Appendix A - Summary of Safety and Effectiveness, Continued

Biocompatibility	All applicable biocompatibility testing was successfully performed for the Vascular Occlusion System.
Summary ofSubstantialEquivalence	The Vascular Occlusion System is substantially equivalent in design, materials, sterilization, and indications for use as other commercially available occlusion devices.1

1 A statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1999

Ms. Martine D. Martino Sr. Regulatory Affairs Associate Cordis Endovascular Systems, Inc. 14000 N.W. 57th Court Miami Lakes, FL 33014

K983483 Re: Vascular Occlusion System Regulatory Class: III (Three) Product Code: 84 MCG Dated: December 21, 1998 December 24, 1998 Received:

Dear Ms. Martino:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 regulation may result in In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation 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.

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Page 2 - Ms. Martine D. Martino

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.

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 qeneral 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,
Thomas J. Collelon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix C - Indications for Use Statement, Continued

Indications for Use Statement

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use i (Per 21 CFR 801.109)

Over-the-Counter Use

Beet R. Demperle
Division Sign-Off

(Division Sign-Off Division of Cardiovascul and Neurological Devi K983483 510(k) Number

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).