ATLANTIS PV IMAGING CATHETER, MODEL 36456

K022860 · Boston Scientific, Target · ITX · Nov 21, 2002 · Radiology

Device Facts

• Record ID: K022860
• Device Name: ATLANTIS PV IMAGING CATHETER, MODEL 36456
• Applicant: Boston Scientific, Target
• Product Code: ITX · Radiology
• Decision Date: Nov 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1570
• 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

Over-the-wire intravascular ultrasound (IVUS) imaging catheter; features telescoping sheath assembly and rotating 15 MHz ultrasonic transducer. Input: acoustic signals from peripheral vasculature. Operation: catheter flushed with heparinized saline for acoustic coupling; connected to MotorDrive Unit (MDU) and IVUS imaging system (ClearView Ultra™ or Galaxy™). Output: real-time ultrasound images displayed on system monitor. Used in clinical settings by physicians during interventional procedures to visualize peripheral pathology; aids clinical decision-making by providing internal vessel imaging. Benefits: enables assessment of peripheral vasculature to guide transluminal interventions.

Clinical Evidence

No clinical data. Evidence consists of bench testing (dimensional, tensile, functional performance), acoustic output testing (within FDA Track 1 limits), animal testing (in-vivo functional/imaging characteristics), and biological safety testing (ISO 10993, bioburden, endotoxin, sterility).

Technological Characteristics

15 MHz rotating ultrasonic transducer; over-the-wire exchange style; dual lumen sheath; radiopaque tip; gold-plated distal housing. Connectivity: electromechanical interface to MDU. Sterilization: E-Beam irradiation. Materials: standard catheter materials consistent with predicates.

Indications for Use

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

Predicate Devices

• BSS Sonicath Ultra™ 6 (K890772)
• BSS Sonicath Ultra™ 3.2 (K970049)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# Boston Scientific Scimed (BSS) Atlantis™ PV Imaging Catheter

- Boston Scientific Scimed Submitted by: IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538
- Contact Person: Irene Jaworski Manager, Regulatory Affairs Tel: [phone] Fax: [phone] [e-mail]
- July 19, 2002 Date prepared:

Atlantis™ PV Imaging Catheter Proprietary Name:

Ultrasound Diagnostic Imaging Catheter Common Name(s): Diagnostic Ultrasound Transducer (901TX) Diagnostic Intravascular Catheter (74DQQ)

Classification Name(s): Diagnostic Ultrasound Transducer, 21 CFR Part 892.1570 (90ITX); Diagnostic Intravascular Catheter, 21 CFR Part 870.1200 (74DQQ)

#### The Atlantis™ PV Imaging catheter is Predicate Device(s): substantially equivalent to the following devices:

| Product | 510(k) | Clearance<br>Date |
|--------------------------------------------|---------|-------------------|
| BSS Sonicath Ultra™ 6<br>(6F / 20 MHz) | K890772 | May 10, 1989 |
| BSS Sonicath Ultra™<br>3.2 (3.2F / 20 MHz) | K970049 | June 20, 1997 |

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#### Description of the Device:

The Atlantis™ PV Imaging Catheter consists of two main assemblies:

- an over-the-wire (OTW) exchange style sheath assembly .
- . an imaging core assembly

The sheath is comprised of the following three sections:

- . Radiopaque soft tip
- Proximal dual lumen .
- Telescoping section ●

The radiopaque soft tip and proximal dual lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the introducer sheath. The telescoping section allows the imaging core to be advanced and retracted within 25 cm of linear movement.

The imaging core is composed of a hi-torque flexible, rotating drive cable with a radially looking 15 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the MotorDrive Unit (MDU) / Instrument. The MDU-Catheter interface consists of an integrated mechanical drive hub and electrical connection.

A flush port with a one-way valve is used to displace air near the transducer. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way valve helps retain saline in the catheter during use.

The catheter sheath is attached to the telescope shaft via a male/female luer connection. The catheter is for use with the BSS ClearView Ultra™ and Galaxy™ IVUS Imaging Systems.

#### Intended Use/Indications:

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 Technology Characteristics an Comparison to Predicate Device:

The Atlantis™ PV Imaging Catheter utilizes the same basic catheter design as the predicate devices, the BSS Sonicath Ultra™ 6 and Sonicath Ultra™ 3.2 Imaging Catheters. These devices have the same intended use, use the same operating principal, and incorporate that same basic catheter design. In addition, the BSS Sonicath Ultra™ 6 has the same shelf life, and is packaged

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Boston Scientific Atlantis™ PV Peripheral Imaging Catheter Special 510(K) Notification

using the same materials and processes as the predicate device. The modifications to Atlantis™ PV Imaging Catheter include a telescoping section, a dual lumen sheath, a radiopaque catheter tip, a proximal flush port with a one-way valve and vent hole, and gold plated distal housing. The Atlantis™ PV Imaging Catheter will be sterilized by E-Beam irradiation, rather than by gamma irradiation, as are the BSS Sonicath Ultra™ 6 and Sonicath Ultra™3.2 Catheters.

#### Non-clinical Test Results:

Bench, acoustic output, animal and biological safety testing demonstrate that the Atlantis™ PV Imaging Catheter is safe and effective for its intended use.

#### Bench Testing:

Bench testing was performed to evaluate the physical integrity and functionality of the catheter. This testing included dimensional testing, sheath bond tensile testing, and a variety of functional performance testing of the sheath and telescoping assembly, the imaging core assembly, and of the final sterile device.

## Acoustic Output Testing:

The Atlantis PV imaging catheter was tested for acoustic output as described in the FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Sept. 30, 1997). Acoustic output test results for the Atlantis™ PV imaging catheter are below the FDA Track 1 limits.

## Animal:

Animal testing was performed to assess the in-vivo functional and imaging characteristics of the Atlantis™ PV imaging catheter. The performance of the Atlantis™ PV imaging Catheter was consistent with the intended clinical use of the device.

## Biological Safety Testing:

The Atlantis™ PV Imaging Catheter was subjected to a series of biocompatibility tests per ISO 10993, bioburden, endotoxin and sterility assurance testing.

#### Conclusion:

The Atlantis™ PV Imaging Catheter utilizes design features and has the same intended use as the predicate devices, the BSS Sonicath Ultra™ 6 and

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Boston Scientific Atlantis™ PV Peripheral Imaging Catheter Special 510(K) Notification

Sonicath Ultra™ 3.2 imaging catheters. The tests support a determination of substantial equivalence of the modified device, the Atlantis™ PV imaging Catheter to the predicate devices.

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Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

NOV 2 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Scimed c/o Ms. Irene Jaworski Manager, Regulatory Affairs IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538

Re: K022860

Trade Name: Atlantis™ PV Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II (two) Product Code: ITX Dated: October 23, 2002 Received: October 24, 2002

Dear Ms. Jaworski:

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 - Ms. Irene Jaworski

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 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 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). 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,

-?

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: | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Atlantis ^TM PV Imaging Catheter |
| Indications for Use: | The Atlantis ^TM 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. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022860

Prescription Use
Per 21 CFR 801.109.

Over the counter Use

OR