CES VASCULAR OCCLUSION SYSTEM

K972881 · Cordis Neurovascular, Inc. · HCG · Jun 4, 1998 · Neurology

Device Facts

• Record ID: K972881
• Device Name: CES VASCULAR OCCLUSION SYSTEM
• Applicant: Cordis Neurovascular, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jun 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CES Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the neurovasculature for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas and other vascular lesions of the brain, spinal cord and spine.

Device Story

CES Vascular Occlusion System comprises platinum alloy pushable coils with synthetic fibers and a coil pusher with radiopaque tip markers. Used in neurovascular interventional radiology to reduce or block blood flow in vessels associated with arteriovenous malformations, fistulas, or other vascular lesions of the brain, spinal cord, and spine. Operated by physicians under fluoroscopic guidance using microcatheters (minimum 0.21" I.D.). Coils are deployed into the target vessel to induce occlusion, thereby managing the vascular lesion and potentially reducing risks associated with abnormal blood flow.

Clinical Evidence

Bench testing only. Biocompatibility testing was successfully performed.

Technological Characteristics

Platinum alloy coils with synthetic fibers; coil pusher includes two radiopaque tip markers. Designed for use with microcatheters (min 0.21" I.D.). Mechanical occlusion principle. No software or electronic components.

Indications for Use

Indicated for the reduction or occlusion of blood flow in neurovascular vessels to manage arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine. Prescription use only.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• CES Pushable Coils (K964367)
• Helix Shaped Coils with Dacron Fibers (K913312)
• Hilal Embolization Microcoil (K901337)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '972881'. The characters are written in a dark ink, and the image is in black and white.

## 510(k) Summary of Oxforty and Effectiveness

General Provisions

- Common names used for this device, include:
- Platinum Fibered Coils .
- Microcoils or Minicoils .

The CES Vascular Occlusion System, consists of :

- TruFill™ Pushable Coils (or CES Pushable Coils), and .
- TruPush™ Embolic Coil Pusher (or CES Coil Pusher) .

The predicate devices are listed in the table below.

## Predicate Devices

The predicate devices are listed in the table below.

| Device | Company | 510 (k) Number,<br>Concurrence Date | Product Code |
|------------------------------------------|-----------------------------------|-------------------------------------|--------------|
| CES Pushable Coils | Cordis Endovascular Systems, Inc. | K964367, 1/30/97 | HCG |
| Helix Shaped Coils<br>with Dacron Fibers | Target Therapeutics | K913312, 1/08/91 | HCG |
| Hilal Embolization<br>Microcoil | Cook, Inc. | K901337, 11/09/90 | HCG |

| Classification | Class III |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Standard | Performance standards have not been established by the FDA under Section<br>514 of the Food, Drug and Cosmetic Act. |
| Intended use | CES Pushable Coils may be used to reduce or block the rate of blood flow in<br>vessels of the neurovasculature for the interventional radiologic management<br>of arteriovenous malformations, arteriovenous fistulas and other vascular<br>lesions of the brain, spinal cord and spine. |
| Device<br>description | The CES Vascular Occlusion System consists of straight and shaped CES<br>Pushable Coils (made from platinum alloy and synthetic fibers) and the CES<br>Coil Pusher (with two radiopaque tip markers). The pushable coils are<br>designed for use under fluoroscopy with microcatheters having a minimum<br>0.21" I.D. |

{1}------------------------------------------------

0-000042 All applicable biocompatibility tests were successfully performed on the CES Biocompatibility Pushable Coils.

The CES Pushable Coils are substantially equivalent in design, materials, Summary of sterilization and indications for use to other commercially available occlusion Substantial Equivalence devices.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the date June 4, 1998. The text is in a simple, sans-serif font. The date is written in a standard format, with the month abbreviated to three letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Martine D. Schneider Sr. Regulatory Affairs Associate Cordis Endovascular 14000 N.W. 57th Court Miami Lakes, Florida 33014

Re: K972881/S1 Trade Name: CES Vascular Occlusion System Requlatory Class: III Product Code: 84HCG Dated: January 29, 1998 Received: January 30, 1998

Dear Ms. Schneider:

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 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 The general controls provisions of the Act 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 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

this response to your premarket 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.

{3}------------------------------------------------

Page 2 - Ms. Schneider

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to one rogalation" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". "

Sincerely yours,

Celia M. Witten. Ph.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K972881 510 (k) Number:_______________________________________________________________________________________________________________________________________________________________

## Indications for Use Statement

CES Pushable Coils may be used to obstruct or reduce the rate of blood flow in vessels of the CES Fusilable Colls may be used to Obstract of rouse and of arteriovenous malformations, newovenous fistulas and other vascular lesions of the brain, spinal cord, and spine.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

a Devices

(Division Sign-Off)

Division of General Restorative 510(k) Number