IMAGER II ANGIOGRAPHIC CATHETER

K011664 · Boston Scientific/Medi-Tech · DQO · Sep 7, 2001 · Cardiovascular

Device Facts

• Record ID: K011664
• Device Name: IMAGER II ANGIOGRAPHIC CATHETER
• Applicant: Boston Scientific/Medi-Tech
• Product Code: DQO · Cardiovascular
• Decision Date: Sep 7, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.

Device Story

Imager II Angiographic Catheter; sterile, single-use diagnostic intravascular catheter. Provides pathway for delivery of contrast media to selected vascular sites. Available in various flush and selective shapes; lengths 40cm, 65cm, 90cm, 100cm. Distal segment radiopaque for fluoroscopic visualization. Used by clinicians in clinical settings to facilitate vascular imaging.

Clinical Evidence

Bench testing only; biocompatibility tested per ISO 10993.

Technological Characteristics

Sterile, single-use diagnostic intravascular catheter. Radiopaque distal segment. Biocompatibility per ISO 10993. Available in multiple lengths (40-100 cm) and shapes.

Indications for Use

Indicated for use in patients requiring contrast media delivery to selected sites in the vascular system.

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.

Predicate Devices

• NightHawk Angiographic Catheter

Submission Summary (Full Text)

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K011664

## SEP - 7 2001

Special Special 510(k)
Imager II Angiographic Catheter
May 29, 2001

## Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: Imager™ II Angiographic Catheter<br>Classification Name: Diagnostic Intravascular Catheter |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | NightHawk Angiographic Catheter |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The IMAGER™II Angiographic Catheters are designed to provide a pathway<br>for delivering contrast media to selected sites in the vascular system. The<br>IMAGER™II Angiographic Catheters are sterile, single-use diagnostic<br>intravascular catheters and are available in a variety of flush and selective<br>shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment<br>of the catheter is radiopaque to aid in visualization of the device under<br>fluoroscopy. |
| Biocompatibility | The IMAGER™II Angiographic Catheters have been tested for<br>biocompatibility per ISO 10993. All data demonstrate this device is<br>biocompatible for its intended use. |
| Summary of<br>Substantial<br>Equivalence | The IMAGER™II Angiographic Catheters have been tested and compared to<br>the predicate device. All data gathered demonstrate this device as<br>substantially equivalent. No new issues of safety or efficacy have been<br>raised. |

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Public Health Service

SEP = 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jodi Lynn Greenizen Boston Scientific/Medi-Tech® One Boston Scientific Place Natick, MA 01760-1537

Re: K011664

> IMAGER™ II Angiographic Catheters Regulation Number: 870.1200 Regulatory Class: II (two) Product Code: DQO Dated: August 13, 2001 Received: August 14, 2001

Dear Ms. Greenizen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

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Page 2 - Ms. Jodi Lynn Greenizen

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 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,

Dale Teh

James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

| 510(k) Number (if known) | K011664 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | IMAGER™II Angiographic Catheters |
| Indications for Use | The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system. |

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| Division<br>510(k) Num | levices | |
|-------------------------------------------------|--------------------------------------------------|----------------|
| Prescription Use<br>Use<br>(Per 21 CFR 801.109) | OR | Over<br>(Optio |
| | Concurrence of CDRH, Office of Device Evaluation | |

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