TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

K030963 · Cordis Neurovascular, Inc. · HCG · Jun 20, 2003 · Neurology

Device Facts

• Record ID: K030963
• Device Name: TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
• Applicant: Cordis Neurovascular, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TRUFILL DCS ORBIT™ Detachable Coil is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: very high risk for management by traditional operative techniques, or, inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

Device Story

System comprises TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe. Coil delivery system (tube and introducer) functions as guidewire and mini infusion catheter to place embolic coil into target vasculature. Syringe (25-cc barrel, pressure gauge, threaded plunger) generates controlled pressure for coil preparation and detachment. Used by neurosurgeons in clinical settings for embolization of intracranial aneurysms, vascular malformations, and peripheral vasculature. Syringe gauge provides visual feedback for detachment settings. Device enables minimally invasive treatment of high-risk or inoperable vascular conditions.

Clinical Evidence

No clinical data. Safety and effectiveness supported by in-vitro bench testing (coil softness, stretch resistance, placement stability, linear stiffness, distal tip angular displacement, flow rate, length/diameter verification, purge reliability, joint strength, detachment reliability, pushability) and animal testing.

Technological Characteristics

System includes embolic coil and manual pressure-controlled syringe. Delivery system acts as guidewire/infusion catheter. Materials biocompatibility verified. Detachment via controlled pressure mechanism. No software or electronic components; purely mechanical device.

Indications for Use

Indicated for patients with intracranial aneurysms deemed high-risk or inoperable by neurosurgical teams, and for patients with neurovascular arteriovenous malformations or fistulae. Also indicated for arterial and venous embolizations in the peripheral vasculature.

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 Detachable Coil System (K014041)

Submission Summary (Full Text)

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JUN 2 0 2003

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Section 4 – Summary of Safety and Effectivene8s 0 0 0 | 0

### 510(k) Summary of Safety and Effectiveness

| Trade Name | The trade name of this device is: TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL®<br>DCS Syringe, also known as the TRUFILL DCS ORBIT™ Detachable Coil System. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | The common name of the device is: Artificial Embolization Device. |
| Classification | These devices have been classified as Class III, per 21 CFR 882.5950 (84HCG), which have<br>been classified within the Division of Cardiovascular, Respiratory, and Neurological Devices. |
| Performance<br>Standards | There are no performance standards applicable under Section 514 of the Food, Drug and<br>Cosmetic Act for Artificial Embolization Devices. |
| Applicant's<br>Name | Cordis Neurovascular, Inc.<br>14000 NW 57 Court<br>Miami, Florida 33014 |
| Contact Person | Alina Caraballo<br>Regulatory Affairs Manager<br>(305) 786-313-6518<br>(305) 786-313-6480 (Fax) |
| Summary Date | April 21, 2003 |
| | Continued on next page |

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K030963 page 2/4

## 510(k) Summary of Safety and Effectiveness, Contineed 0000 | I

The TRUFILL DCS ORBIT™ Detachable Coil is intended for embolizing certain intracranial TRUFILL DCS aneurysms that - because of their morphology, their location, or the patient's general medical ORBIT™ condition - are considered by the treating neurosurgical team to be: Detachable Coil Intended Use very high risk for management by traditional operative techniques, or, 1. inoperable, 2. and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

> The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

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

The table below compares the TRUFILL DCS ORBIT™ Detachable Coil System with the Comparative Characteristics currently marketed device TRUFILL® DCS Detachable Coil System.

| Characteristics | TRUFILL DCS ORBIT™ Detachable Coil<br>System |
|-------------------------------------|---------------------------------------------------------------------------------------------------|
| Anatomical Sites | Same as predicate device |
| Intended Use | Same as predicate device |
| Method of Coil Attachment | Same as predicate device |
| Method of Coil Detachment | Same as predicate device |
| Detachment Feedback | Same as predicate device |
| Coil Shape Configurations | Same as predicate device (Added Mini Complex<br>Configuration) |
| Coil Softness Configurations | Same as predicate device (Changed the<br>nomenclature of the Basket Configuration to<br>Standard) |
| Coil Wire Outer Diameter (in) | Same as predicate device |
| Primary Coil Diameter (in) | Same as predicate device |
| Secondary Coil Diameter (mm) | Same as predicate device |
| Coil Length (cm) | Same as predicate (Addition of 1.5 coil length) |
| Coil Material | Same as predicate device |
| Delivery System Usable Length (cm) | Same as predicate device |
| Delivery System Outer Diameter (in) | Downsized version of the predicate device |
| Delivery System Body Design | Same as predicate device |
| Radiopaque Marker Bands | Same as predicate device |

Continued on next page

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# KO30963

## 510(k) Summary of Safety and Effectiveness, Contified 000 | 2

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

| Device | Company | 510(k)<br>Number /<br>Concurrence<br>Date | Product<br>Code | Predicate for: |
|-------------------------------------------|----------------------------------|-------------------------------------------|-----------------|-----------------------------------------------------------------------------------------------------------|
| TRUFILL® DCS<br>Detachable Coil<br>System | Cordis<br>Neurovascular,<br>Inc. | K014041 /<br>3/7/02 | HCG | Intended Use<br>Embolic Coil<br>Delivery System<br>Detachment Mechanism<br>Manufacturing<br>Sterilization |

Device Description

The TRUFILL DCS ORBIT™ Detachable Coil System is comprised of the TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe.

- The TRUFILL DCS ORBIT™ Detachable Coil consists of a delivery system . (delivery tube and coil introducer) and an embolic coil. The delivery tube segment comprises the body of the device and has the combined functionality of a guidewire and a mini infusion catheter. The coil introducer is a tube designed to protect the detachable embolic coil in the packaging dispenser and provide support for introducing the embolic coil into the infusion catheter. The embolic coil is the implantable segment of the device.
- The TRUFILL® DCS Syringe is used to generate a controlled pressure for . preparation and detachment of the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe consists of a 25-cc barrel with a pressure gauge, a threaded plunger assembly with a locking wing mechanism, and a flexible high-pressure extension tube. The gauge faceplate is calibrated for three settings for use with the TRUFILL® family of Detachable Coils.

Continued on next page

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K030963 page 4/4

# 510(k) Summary of Safety and Effectiveness, Continueθ - 0 0 0 0 1 3

Non-Clinical Performance Data

The following in-vitro testing was conducted to support substantial equivalence to the predicate device.

| Comparative Testing |
|------------------------------------|
| Coil Softness / Stretch Resistance |
| Embolic Coil Placement Stability |
| Linear Stiffness Test |
| Distal Tip Angular Displacement |
| Flow Rate Test |

The following in-vitro and animal testing was conducted to demonstrate the safety and effectiveness of the device, and to demonstrate that the device performs as it is intended.

| Performance Testing |
|-----------------------------------------------------|
| Embolic Coil Length Verification |
| Delivery System Outer Diameter Verification |
| Purge Reliability and Purge Confirmation |
| Delivery Tube / Introducer Zip / Unzip Verification |
| Embolic Attachment Strength Test |
| Distal Joint Pull Strength Test |
| Proximal (Transition) Joint Strength Test |
| Detachment Reliability Verification |
| Pushability Testing |

Biocompatibility All appropriate biocompatibility tests were successfully performed on the materials used to manufacture the TRUFILL DCS ORBIT™ Detachable Coil System.

Conclusion Results of the in-vitro and animal testing demonstrated that the TRUFILL DCS ORBIT™ Detachable Coil System is substantially equivalent to the predicate device, TRUFILL® DCS Detachable Coil System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.

Public Health Service

JUN 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Alina Caraballo Regulatory Affairs Manager Cordis Neurovascular, Inc. P.O. Box 025700 Miami, Florida 33102-2700

Re: K030963

Trade/Device Name: TRUFILL DCS ORBIT™ Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: March 26, 2003 Received: March 27, 2003

Dear Ms. Caraballo:

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 - Ms. Alina Caraballo

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]. 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 premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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KC30963

Page

510(k) Number (if known):

#### Device Name: I RUFILI. IX S ORBIT™ Detachable Coil System comprised of the TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe

#### Indications for Use Statement

The TRUFILL DCS ORBIT™ Detachable Coil is intended for embolizing certain intracranial aneurysms that because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:

very high risk for management by traditional operative techniques, or, a)

b) inoperable,

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
✓

OR

Over-The-Counter Use

Muriam C. Provost

Division of General. Restorative and Neurological Devices

510(k) Number k030963