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

K014041 · Cordis Neurovascular · HCG · Mar 7, 2002 · Neurology

Device Facts

• Record ID: K014041
• Device Name: TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
• Applicant: Cordis Neurovascular
• Product Code: HCG · Neurology
• Decision Date: Mar 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRUFILL® DCS Detachable Coil System 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: a) very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL® DCS Detachable Coil System is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS Detachable Coil.

Device Story

TRUFILL® DCS Detachable Coil System consists of implantable platinum/tungsten alloy embolic coil and hydraulic delivery system; used for embolization of intracranial aneurysms, AVMs, AVFs, and peripheral vasculature. System includes delivery tube, coil introducer, and 25-cc syringe with pressure gauge. Operation: coil delivered via microcatheter; detachment achieved via hydraulic pressure; pressure gauge provides detachment feedback. Used by neurosurgeons in clinical settings. Device provides alternative to traditional surgery for high-risk/inoperable patients; facilitates occlusion of vascular malformations.

Clinical Evidence

Clinical testing demonstrated safety and effectiveness comparable to the predicate device. Supporting data included in-vitro bench testing (radiopacity, coil softness, wall force, migration, tip displacement) and animal studies. No specific clinical trial metrics (e.g., p-values, AUC) provided in summary.

Technological Characteristics

Implantable coil: 92% Platinum / 8% Tungsten alloy; helical or complex shapes. Delivery system: microcatheter-compatible, hydraulic detachment mechanism. Syringe: 25-cc barrel, pressure gauge, high-pressure extension tube. Sterilization: not specified. Connectivity: none.

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

• Guglielmi Detachable Coil (GDC) (K951256, K960705, K962503, K971395, K991139, K993417, K993418, K001083, K002181)

Submission Summary (Full Text)

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7 2002 MAR

# Summary of Safety and Effectiveness

# 510(k) Summary of Safety and Effectiveness

| Trade name | The trade name of this device is: TRUFILL® DCS Detachable Coil and TRUFILL® DCS<br>Syringe, also known as the TRUFILL® Detachable Coil System (DCS). |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | The common name of this device is: Artificial Embolization Device. |
| 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>[phone]<br>[phone] fax |
| Summary Date | December 5, 2001 |
| | Continued on next page |

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K014041

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

The TRUFILL® DCS Detachable Coil System is intended for embolizing certain intracranial TRUFILL® DCS aneurysms that - because of their morphology, their location, or the patient's general medical Detachable Coil condition - are considered by the treating neurosurgical team to be: Intended Use 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 Detachable Coil System is also intended for arterial and venous embolizations in the peripheral vasculature. 2017年07月25日 11:54:00 AM R 11:50 PM R 11:00 AM 10:00 PM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 1 The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS TRUFILL® DCS Syringe Intended Detachable Coil. Use The table below compares the TRUFILL® DCS Detachable Coil System with the currently

Comparative Characteristics

marketed device Target's Guglielmi Detachable Coil (GDC).

| Characteristics | Cordis Neurovascular, Inc.<br>TRUFILL® DCS Detachable Coil<br>and TRUFILL® DCS Syringe | Target's Guglielmi Detachable Coil<br>GDC |
|------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Anatomical Sites | Peripheral and Neurovasculature | Peripheral and Neurovasculature |
| Intended Use | Aneurysms, AVMs, AVFs, Long-Term<br>Use | Aneurysms, AVMs, AVFs, Long-Term<br>Use |
| Method of Coil Attachment | Mechanical Elastomeric Press Fit | Gold/Tin Solder Joint |
| Method of Coil Detachment | Hydraulically expandable gripper<br>material | Electrolytically dissolvable solder joint |
| Detachment Feedback | Pressure Gauge with detachment<br>indicator | Voltmeter and ammeter with LED<br>detachment indicator |
| Coil Shape Configurations | Helical and Complex | Helical |
| Coil Wire Outer Diameter (in) | 0.0015-0.004 | 0.00175-0.004 |
| Primary Coil Diameter (in) | 0.010-0.016 | 0.0095-0.015 |
| Secondary Coil Diameter (mm) | 2 - 20 | 2-20 |
| Coil Length (cm) | 2 - 30 | 2 - 30 |
| Coil Material | Platinum/Tungsten | Platinum/Tungsten |
| Delivery System Usable Length (cm) | 155-210 | 175 - 195 |
| Delivery System Body Design | Microcatheter design | Guidewire design |
| Radiopaque Marker Bands | Platinum/Tungsten coils, Window design | Platinum/Tungsten coil with Gold/Tin<br>solder attachment joints. T design |

Continued on next page

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

| Device | Company | 510 (k) Number/<br>Concurrence Date | Product<br>Code | Predicate for: |
|------------------------------|------------------------------|-------------------------------------|-----------------|----------------------|
| Guglielmi Detachable<br>Coil | Boston Scientific,<br>Target | K951256 | HCG | Embolic coil |
| | | K960705 | | Delivery system |
| | | K962503 | | Detachment mechanism |
| | | K971395 | | Sterilization |
| | | K991139 | | |
| | | K993415 | | |
| | | K993417 | | |
| | | K993418 | | |
| | | K001083 | | |
| | | K002181 | | |

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

#### Device Description

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

- The TRUFILL® DCS Detachable Coil consists of a delivery system (delivery tube and . coil introducer) and an embolic coil. The delivery tube is comprised of a hub, a strain relief, a stiff proximal section, and a floppy distal section. 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 microcatheter. The embolic coil is the implantable segment of the device. It is comprised of a vasocclusion coil wound from a platinum alloy wire (92% Platinum / 8% Tungsten) into a primary coil and then formed into a secondary helical or complex shape.
- 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 with a male luer connector.

Continued on next page

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014041

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

Non-Clinical Performance Data

AMA

,

The following in-vitro and animal testing was presented to support substantial equivalence to the predicate device.

| Comparative Testing |
|-----------------------------------------------------------|
| Embolic coil radiopacity |
| Markerband radiopacity |
| Embolic coil softness |
| Force exerted on the wall of a simulated aneurysm |
| Force required to push the device through a microcatheter |
| Migration in a simulated worst case fistula model |
| Distal tip softness |
| Distal tip angular displacement |
| Animal studies |

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

Clinical Data Results of clinical testing demonstrated comparable safety and effectiveness to the predicate device.

2017年 - 2012 - 10:50 - 10:50 - 10:50 - 10:50 - 10:50 - 10:50 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00

Conclusion

Results of in-vitro, animal, and clinical testing demonstrated that the TRUFILL® DCS Detachable Coil System is substantially equivalent to the predicate device, Target's GDC.

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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 a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and a serpent winding around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2002 MAR

Ms. Alina Caraballo Manager, Regulatory Affairs Cordis Neurovascular, Inc. 14000 NW 57th Court Miami Lakes, Florida 33014

Re: K014041

Trade/Device Name: TRUFILL® DCS Detachable Coil System Regulation Number: 882.5950 and 870.3300 Regulation Name: Artificial embolization device, Arterial embolization device Regulatory Class: III Product Code: HCG and KRD Dated: December 5, 2001 Received: December 7, 2001

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 prematicated predicated on "The 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compliance at [phone] Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general mistmances, 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

for 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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510(k) Number (if known): K O1 YOU (

Device Name: TRUFILL® DCS Detachable Coil System comprised of the TRUFILL® DCS Detachable Coil and TRUFILL® DCS Syringe

#### Indications for Use Statement

The TRUFILL® DCS Detachable Coil System 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)

inoperable, b)

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

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

The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS Detachable Coil.

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K014041

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OR

Over-The-Counter Use