ATLANTIS PV

K050684 · Boston Scientific Corp · DQO · May 20, 2005 · Cardiovascular

Device Facts

• Record ID: K050684
• Device Name: ATLANTIS PV
• Applicant: Boston Scientific Corp
• Product Code: DQO · Cardiovascular
• Decision Date: May 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

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

Device Story

Atlantis™ PV Imaging Catheter is a diagnostic intravascular ultrasound (IVUS) catheter. It captures ultrasound images of peripheral vasculature to assist clinicians in evaluating peripheral pathology. The device is used during transluminal interventional procedures. It functions by transmitting and receiving ultrasound signals to generate real-time images of the vessel lumen and wall. These images are displayed to the physician to guide clinical decision-making during interventions. The device is intended for use by trained medical professionals in a clinical or surgical setting.

Technological Characteristics

Diagnostic intravascular ultrasound catheter; utilizes ultrasonic transducer technology for imaging; intended for peripheral vascular applications; classified under 21 CFR 892.1370 and 21 CFR 870.1200 (referenced as 07728 in text).

Indications for Use

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

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2005

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

Re: K050684

: K050064
Trade Name: Atlantis™ PV Imaging Catheter Trade Name: Atlantis Regulation Number: 21 CFR 892.1370 and 21 CFR 07728
Regulation Name: Diagnostic Intravascular Catheter and Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: DQO and ITX Dated: April 21, 2005 Received: April 22, 2005

Dear Mr. Phillips:

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We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Secton 510(K) premained in movinent (for the indications
referenced above and have determined the devices market in interstate referenced above and have determined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstat for use stated in the enclosure) to legally market peoples and our of the America Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Dr commerce prior to May 28, 1976, the encoment and of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Federal (PMA) devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the general cegistration, listing of
general controls provisions of the Act include requirements for and instrumding and general controls provisions of the Act Include requirements of the many of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into elucit cass if topodia ions affecting your device can
may be subject to such additional controls. Existing major regulation, FD may be subject to such additional controis. Existing major regardo 2010 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. I be found in the Code of Federal Regulations, Prac Bay Car,
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 Please be advised that FDA s issualled of a succession of the requirements of the Act
that FDA has made a determination that your device complies with of the Act that I DA has made a determination that your correst by other Federal agencies. You must or any Federal statules and regulations daministered of registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with an the Act 3 requirements, me; good manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing additionals allestron CFR Part 807), labeling (21 CFR 1 at 801), good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni forth in the quality systems (QD) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); vays Section S product faction control provisions (Declibis of I wice as described in your Section 510(k)
This letter will allow you to begin marketing your device of section of course to l I his letter will anow you to begin hanksting of substantial equivalence of your device to a legally premarket notification. The PDA mining of substances of the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), piease
s the regulation and 11, 2001 - the color and consected as regulation entit If you desire specific advice for your de vice of an a Also, please note the regulation entitled, comaci the Office of Complance at (210) 276 - 124 - 124 Part 807.97). You may obtain " Misoranding by relefence to premanto nonificancement of the Act from the Division of Small other general information on your responsibility of the toll-free number [phone] or and Manufacturers, international and Colisanet Fristicaller and consideralindustry/support/index.html.

Sincerely yours,

Brimmer for

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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## Indications for Use Statement

| 510(k) Number: | K050684 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Atlantis™ PV Imaging Catheter |
| Indications for Use: | The Atlantis™ PV Imaging Catheter is intended for<br>ultrasound examination of peripheral pathology only.<br>Intravascular ultrasound imaging is indicated in<br>patients who are candidates for transluminal<br>interventional procedures. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 807 Subpart C)

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

AND/ OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bbommer
Division Sign Off

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

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Confidential