BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER

K022621 · Boston Scientific Corp · DQO · Sep 4, 2002 · Cardiovascular

Device Facts

• Record ID: K022621
• Device Name: BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
• Applicant: Boston Scientific Corp
• Product Code: DQO · Cardiovascular
• Decision Date: Sep 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

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

Device Story

The Imager™ II Angiographic Catheter is a sterile, single-use diagnostic intravascular catheter. It provides a pathway for delivering contrast media to selected vascular sites. The distal segment is radiopaque to facilitate visualization under fluoroscopy. The device is used by clinicians in a clinical setting to assist in diagnostic imaging procedures. It is available in various flush and selective curve styles with lengths ranging from 40 cm to 100 cm.

Clinical Evidence

Bench testing only. Testing included dimensional verification, guidewire compatibility, tensile strength, torque response, insertion force, static burst strength, and flow rate. Biocompatibility and shelf life were established via reference to predicate device data.

Technological Characteristics

Diagnostic intravascular catheter; radiopaque distal segment for fluoroscopic visualization; available in 4F size with various flush and selective curve configurations; lengths 40-100 cm; sterile, single-use; non-powered mechanical device.

Indications for Use

Indicated for use as a pathway for delivering contrast media 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

• Boston Scientific Imager™ II 4F, 5F Flush and 5F Selective Angiographic Catheter (K011664)

Submission Summary (Full Text)

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## (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

### General Provisions 6.1

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, Minnesota 55311 |
|---------------------------------|-------------------------------------------------------------------------------------|
| Contact Person | Heidi M. Erickson<br>[phone] |
| Classification Name | Diagnostic Intravascular<br>Catheters (21CFR Part 970.1200) |
| Common or Usual Name | Angiographic Catheter |
| Proprietary Name | Boston Scientific Imager™ II 4F Selective<br>Angiographic Catheter |
| Name of Predicate Device | Boston Scientific Imager™ II 4F, 5F Flush<br>and 5F Selective Angiographic Catheter |

### 6.3 Device Description

6.2.1

The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™ Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective curve styles with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.

#### 6.4 Intended Use

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

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### Section 6: Summary of Safety and Effectiveness

KO22621

### Summary of Technological Characteristics 6.5

Same as currently marketed Imager™ II Angiographic Catheters, cleared for market under K011664, September 7, 2001.

### 6.6 Non-clinical Test Summary

Functional testing consisted of dimensional verification, guidewire compatibility, tensile strength, torque response, insertion force, static burst strength, and flow rate. Biocompatibility and product shelf life testing were previously conducted on the predicate devices. Test results verified that the 4F Selective Imager™ Angiographic Catheters are adequate for the intended use. The 4F Selective Imager™ II Angiographic Catheters are considered substantially equivalent to the currently marketed 4F and 5F Flush and 5F Selective Imager™ Angiographic catheters based on a comparison of the intended use, the device design, and the results of testing and evaluation.

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### Public Health Service

4 2002 SEP

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Ms. Heidi M. Erickson One Scimed Place Maple Grove, MN 55311

Re: K022621

> Boston Scientific Imager™ II 4F Selective Angiographic Catheter Regulation Number: 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: 74 DQO Dated: August 6, 2002 Received: August 7, 2002

Dear Ms. Erickson:

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.

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);

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Page 2 - Ms. Heidi M. Erickson

labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Da Teln

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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022621

# Section 4:

Indications for Use

510(k) Number (if known) _______________

Device Name: 4F Selective Imager™ II Angiogaphic Catheter

Indications for Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)