VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)

K071962 · Cordis Neurovascular, Inc. · HCG · Sep 26, 2007 · Neurology

Device Facts

• Record ID: K071962
• Device Name: VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
• Applicant: Cordis Neurovascular, Inc.
• Product Code: HCG · Neurology
• Decision Date: Sep 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows: Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

Device Story

Vascular Occlusion System consists of TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher. Device used in interventional radiology for embolization procedures in neuro and peripheral vascular systems. Physician loads embolic coil into proximal end of microcatheter; uses Coil Pusher to advance coil through catheter lumen until it exits distal tip. System facilitates mechanical occlusion of vascular lesions; benefits patient by reducing or blocking blood flow to malformations or fistulas. Device is manual; no electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence supported by in-vitro and in-vivo design verification and validation testing, including mechanical integrity (joint strength, turns to failure), packaging integrity, and functional performance (pushability, retractability).

Technological Characteristics

Manual vascular embolization delivery system. Components include corewire, PTFE sleeve, and solder joints. Materials include PTFE. No energy source, software, or connectivity. Sterilization method not specified. Dimensions defined by proximal/distal joint ODs and taper lengths.

Indications for Use

Indicated for patients requiring reduction or blockage of blood flow in peripheral and neurovascular vessels; specifically for interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

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

• TRUPUSH® Coil Pusher (K983483)

Submission Summary (Full Text)

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K071962

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Johnson-Johnson company

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SEP 2 6 2007

# 510(k) Summary of Safety and Effectiveness

| Submitter's Name/Contact Person | Amarilys Machado<br>Manager, Regulatory Affairs<br><br>Cordis Neurovascular, Inc.<br>14000 NW 57th Court<br>Miami Lakes, Florida 33014<br><br>Ph. 786 313 6493<br>Fax. [phone]<br>[e-mail] |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name / Common Name | The trade name is :<br>Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher)<br><br>The common name is:<br>Artificial Embolization Device |
| Classification | This is a Class II Device, per 21 CFR 882.5950 (84HCG) |
| Performance Standard | The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this device. |
| Intended use | The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:<br><br>Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine. |
| Device Description | The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter. |

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**Cordis**®
a Johnson & Johnson company

KO 71962

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Predicate Devices The predicate devices are listed in the table below:

| Device | Company | Product Code | 510(k) Number | Predicate for:<br>(if multiple predicates) |
|-------------------------|-------------------------------|--------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------|
| TRUPUSH®<br>Coil Pusher | Cordis<br>Neurovascular, Inc. | K983483 | HCG | - Intended Use<br>- Design<br>- Operating<br>Principle<br>- Materials<br>- Sterilization<br>- Shelf Life<br>- Manufacturing<br>Process |

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KU71962

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#### Summary of Studies

The in-vitro and in-vivo testing was conducted to support substantial equivalence to the predicate device, addressing the process changes, packaging changes and manufacturing site transfer.

#### Design Verification Testing:

- . Total Product Length
- � Taper Length
- OD of the Proximal Joint
- . OD of the Distal Joint
- . OD of the Proximal End of the PTFE Sleeve
- . Proximal Marker Position
- Distal Placement of the PTFE Sleeve
- . PTFE Sleeve Visual Inspection
- . Distal End of PTFE Sleeve Visual Inspection
- . Overall Visual Inspection
- . Distance from the Proximal End of the PTFE Sleeve to the Corewire Taper
- t Distal Solder Joint Length
- . Distal Solder Joint Visuals
- . Turns to Failure
- . Distal Joint Strength
- . Package Integrity
- . Package Challenge
- Seal Integrity Test (Dye Penetration) .
- Packaging-Seal Strength (Pull Test) .
- . Product Migration

#### Design Validation Testing:

- 3-cavity torque device clip .
- Pushability .
- Retractability .

Summary of Substantial Equivalence

The proposed TRUPUSH® Coil Pusher is similar in its basic design, construction, indication for use, and performance characteristics to the predicate device the current TRUPUSH® Coil Pusher.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cordis Neurovascular, Inc. % Amarilys Machado Regulatory Affairs Manager 14000 Northwest, 57th Court Miami Lakes, Florida 33014

SEP 26 2007

Re: K071962

Trade/Device Name: Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: August 27, 2007 Received: August 28, 2007

Dear Amarilys Machado:

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, Drug, 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, FDA may publish further announcements concerning your device in the Federal Register.

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

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Page 2 -- Amarilys Machado

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Ftz
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 CFF 20014 Only the Native File to be Used Intended Use Statement

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## Indications for Use

510(k) Number (if known):

Device Name: TRUPUSH® Coil Pusher

### Indications For Use:

The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:

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

J

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Prescription Use X (Part 21 CFR 801 Subpart D)

1071962
AND/0B10(k)Number-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)