THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

K063254 · Cordis Neurovascular, Inc. · HCG · Dec 7, 2006 · Neurology

Device Facts

• Record ID: K063254
• Device Name: THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
• Applicant: Cordis Neurovascular, Inc.
• Product Code: HCG · Neurology
• Decision Date: Dec 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

Device Story

TRUFILL® DCS Syringe II is a manual medical device used to generate controllable pressure for the preparation and detachment of TRUFILL® family detachable coils; used in neurovascular embolization procedures. Device consists of a 14-cc barrel, pressure gauge, threaded plunger assembly with locking mechanism, and flexible high-pressure extension tube with male luer connector. Gauge faceplate is calibrated specifically for TRUFILL® DCS and TRUFILL® DCS ORBIT™ coils. Operated by clinicians in a clinical setting to ensure proper coil purge and detachment. Output is controlled hydraulic pressure; healthcare providers use the gauge to monitor pressure levels during the detachment process, ensuring safe and effective coil deployment.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included gauge accuracy, pressure cycling, luer lock dimensional verification, chemical compatibility, joint pull, device integrity, torque, flush particulate, and biocompatibility. Design validation confirmed performance for purge and detachment of TRUFILL® DCS and TRUFILL® DCS ORBIT™ coils.

Technological Characteristics

Manual syringe assembly; 14-cc barrel; pressure gauge; threaded plunger with locking mechanism; flexible high-pressure extension tube with male luer connector. Calibrated for specific coil family pressure requirements. Non-powered, mechanical device.

Indications for Use

Indicated for use with the TRUFILL® family of Detachable Coils for artificial embolization procedures.

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

• TRUFILL® DCS Syringe (K030963)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| Submitter's<br>Name/Contact<br>Person | Amarilys Machado<br>Regulatory Affairs Manager |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cordis Neurovascular, Inc.<br>14000 N.W. 57th Court<br>Miami Lakes, Florida 33014<br>786-313-6493<br>786-313-6480 (Fax)<br>[e-mail] |
| | October 26, 2006<br>DEC - 7 2006 |
| Trade Name /<br>Common Name | The trade name is:<br>The TRUFILL® DCS Detachable Coil System, comprised of the TRUFILL® DCS<br>Detachable Coil and the TRUFILL® DCS Syringe or the TRUFILL® DCS Syringe IIThe TRUFILL DCS ORBIT™ Detachable Coil System, comprised of the TRUFILL<br>DCS ORBIT™ Detachable Coil and the TRUFILL® DCS Syringe or the TRUFILL®<br>DCS Syringe II |
| | The common name for the TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coil<br>Systems is: Artificial Embolization Device. |
| Classification | These devices have been classified as Class II, per 21 CFR 882.5950 (84HCG), which have<br>been classified within the Division of Cardiovascular, Respiratory, and Neurological Devices. |
| Performance<br>Standard | There are no performance standards applicable under Section 514 of the Food, Drug and<br>Cosmetic Act for Artificial Embolization Devices. |
| Intended use | The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of<br>Detachable Coils. |
| Device<br>Description | The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threaded<br>plunger assembly with a locking mechanism, and a flexible high-pressure extension tube with<br>a male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCS<br>ORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL®<br>family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllable<br>pressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils. |

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**Cordis**®

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## 510(k) Summary of Safety and Effectiveness

Predicate Devices The predicate device is listed in the table below:

| Device | Company | Product<br>Code | 510(k)<br>Number | Predicate for:<br>(if multiple<br>predicates) |
|-------------------------|----------------------------|-----------------|------------------|--------------------------------------------------------|
| TRUFILL® DCS<br>Syringe | Cordis Neurovascular, Inc. | HCG | K030963 | Intended Use Design Detachment Mechanism Sterilization |

Summary of Studies

The following table summarizes the in-vitro laboratory performance testing that was conducted to demonstrate the safety and effectiveness of the TRUFILL® DCS Syringe.11 and to demonstrate that the device performs as it is intended.

| Performance and Safety Testing |
|----------------------------------------------|
| Gauge Accuracy and Pressure Cycling |
| Luer Lock Connector Dimensional Verification |
| Chemical Compatibility Testing |
| Joint Pull Test |
| Device Integrity Test |
| Torque Test |
| Device Flush Particulate Test |
| Biocompatibility Testing |

The following table summarizes the in-vitro testing that was conducted to validate the design of the TRUFILL® DCS Syringe II and to ensure that the device specifications conform to the user needs and intended use.

| Design Validation Testing |
|-------------------------------------------------------------|
| Syringe Packaging |
| Purge and Detachment of TRUFILL® DCS Detachable Coils |
| Purge and Detachment of TRUFILL DCS ORBIT™ Detachable Coils |
| Syringe Integrity |
| Ability to Pressurize Syringe |

Summary of Substantial Equivalence

The TRUFILL® DCS Syringe II is similar in its basic design, construction, indication for use, and performance characteristics to the predicate device, the TRUFILL® DCS Syringe.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC - 7 2006

Re: K063254

Trade/Device Name: TRUFILL® DCS Syringe II Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: October 26, 2006 Received: October 27, 2006

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. Iisting 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 (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.

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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,

Mark N. Melkerson
Director

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

Enclosure

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Image /page/4/Picture/1 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, serif font, with a registered trademark symbol next to it. Below the company name, in a smaller font, is the text "a Johnson & Johnson company."

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): KOG 3 2S 4

Device Name: TRUFILL® DCS Syringe II

Indications For Use:

The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-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)

| | <center>(Division Sign-Off)</center> |
|--|--------------------------------------|
|--|--------------------------------------|

Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K063254 |
|---------------|---------|
|---------------|---------|