SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020

K041818 · Boston Scientific Corp · ITX · Nov 10, 2004 · Radiology

Device Facts

• Record ID: K041818
• Device Name: SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
• Applicant: Boston Scientific Corp
• Product Code: ITX · Radiology
• Decision Date: Nov 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The Sonicath Ultra™ Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Device Story

Sonicath Ultra Imaging Catheter; intravascular ultrasound (IVUS) device. Used for visualization of peripheral vasculature. Input: ultrasound signals generated by catheter transducer. Output: real-time ultrasound images for display on compatible IVUS console. Used in clinical settings during transluminal interventional procedures; operated by physicians. Provides internal vessel imaging to assist clinicians in assessing pathology and guiding interventional therapy. Benefits: improved visualization of vessel morphology and pathology during minimally invasive procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Diagnostic ultrasonic transducer; peripheral intravascular imaging catheter. Class II device (21 CFR 892.1570).

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring ultrasound examination of peripheral intravascular pathology.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2004

Boston Scientific / Scimed c/o Mr. Robert Z. Phillips Manager, Regulatory Affairs IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538-6515

Re: K041818

Trade Name: Sonicath Ultra Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II (two) Product Code: ITX Dated: October 18, 2004 Received: October 19, 2004

Dear Mr. Phillips:

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. Robert Z. Phillips

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,

Bhummer for
Brad D. Zuckerman, MD

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

Enclosure

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## Indications for Use

Sonicath Ultra™ Imaging Catheter

510(k) Number (if known):

K041818

Device Name:

Indications For Use:

The Sonicath Ultra™ Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bummer

Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_ 16

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