INTERLOCKING DETACHABLE COIL SYSTEM (IDC)

K040342 · Boston Scientific Corp · KRD · Apr 13, 2004 · Cardiovascular

Device Facts

• Record ID: K040342
• Device Name: INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
• Applicant: Boston Scientific Corp
• Product Code: KRD · Cardiovascular
• Decision Date: Apr 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IDC System is indicted to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

Device Story

The Interlocking Detachable Coil (IDC) System is an arterial embolization device used to obstruct or reduce blood flow in peripheral vasculature. The system consists of a platinum coil attached to an interlocking coil pusher. It is delivered via a .018" compatible microcatheter under fluoroscopic guidance. The interlocking mechanism allows the clinician to advance or retract the coil for precise, controlled placement before final detachment. The device is intended for use by physicians in a clinical setting. By enabling controlled embolization, the device assists in managing peripheral vascular conditions requiring flow reduction.

Clinical Evidence

Bench testing only. Functional and integrity testing, along with biocompatibility testing per ISO-10993, were performed to demonstrate substantial equivalence. No clinical data was required or provided.

Technological Characteristics

Materials: Platinum. Delivery: Interlocking coil pusher system. Compatibility: .018" microcatheter. Imaging: Radiopaque tip markers for fluoroscopic visualization. Energy: None (mechanical). Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for obstruction or reduction of blood flow in the peripheral vasculature. Not for neurovascular use.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

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 § 870.1(e).

Predicate Devices

• Coil Pusher (K911779)
• Boston Scientific Target Coil Pusher - 16 (K891688)
• Boston Scientific Target GDC Coil (K914786)
• Boston Scientific Target Occlusion Coils (K901721)

Submission Summary (Full Text)

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APR 1 3 2004

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Interlocking Detacha 510(k) PreMarket Notification-Traditional February 5, 2004

## SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to § 513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "… adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation has chosen to submit a summary of information respecting safety and effectiveness. According to 6 513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

The summary regarding the adverse health effects of the proposed IDC System is as follows:

| Common Name | Arterial Embolization Device |
|----------------------------|------------------------------------------------------------------------------------------------------------|
| Trade Name | Interlocking Detachable Coil System (IDC) |
| Device Classification Name | Arterial Embolization Device<br>Product Code - 74KRD<br>Regulation Number - 870.3300 |
| Device Classification | Class III |
| Device Panel | Cardiovascular |
| Performance Standards | No formal performance standards have been established by the Food and Drug Administration for this device. |

Predicate Devices

The predicate devices are listed in the table below.

| Table 3 | | |
|--------------------------|---------|------------------------------------|
| Device | Company | 510(k) Number/<br>Concurrence Date |
| Coil Pusher | | K911779 |
| Boston Scientific Target | | K914786 |
| Coil Pusher - 16 | | K891688 |
| Boston Scientific Target | | |
| GDC Coil | | |
| Boston Scientific Target | | |
| Occlusion Coils | | K914786 |
| Boston Scientific Target | | K901721 |
| | | K911779 |
| | | K891688 |

All of the devices mentioned above have been determined substantially equivalent by FDA

Device Description The Boston Scientific IDC System is manufactured from platinum and comes attached to an Interlocking Coil Pusher. It is designed to be delivered under fluoroscopy using a .018" compatible microcatheter with two radiopaque tip makers. The interlocking design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in precise, controlled delivery.

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## Safety and Performance:

Functional and integrity bench testing and Biocompatibility testing to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evalution and Testing" were performed, and the data supported the substantial equivalence of the IDC System to the predicate devices.

## Conclusion:

Based on the Indictions for Use, technical characteristics testing the IDC System has been show to be substantially equivalent to the predicate device.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2004

Boston Scientific Corporation c/o Mr. Arthur Friedman Vice President, Regulatory Affiars One Boston Scientific Place Natick, MA 01760

K040342 Re:

Interlocking Detachable Coil System (IDC System) Regulation Number: 21 CFR 870.3300 Regulation Name: Embolization Arterial Device Regulatory Class: III (three) Product Code: KRD Dated: February 5, 2004 Received: February 12, 2004

Dear Mr. Friedman:

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.

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Page 2 - Mr. Arthur Friedman

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. 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/dsma/dsmamain.html

Sincerely yours,

Duna R. bohner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Interlocking Detachabe Coil 510(k) Premarket Notification - Traditional February 5, 2004

## Indications for Use

510(k) Number (if known):

Interlocking Detachable Coil System (IDC System) Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The IDC System is indicted to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

Prescription Use _ × (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)

Dung R. b. line

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K040342

Confidential Boston Scientific Corporation