IMAGER II ANGIOGRAPHIC CATHETERS

K120893 · Boston Scientific Corp · DQO · Mar 29, 2012 · Cardiovascular

Device Facts

• Record ID: K120893
• Device Name: IMAGER II ANGIOGRAPHIC CATHETERS
• Applicant: Boston Scientific Corp
• Product Code: DQO · Cardiovascular
• Decision Date: Mar 29, 2012
• 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 including the carotid arteries.

Device Story

Imager II Angiographic Catheter is a sterile, single-use diagnostic intravascular catheter; 4F and 5F sizes; available in various flush and selective shapes; lengths 40-100 cm. Distal segment is radiopaque for fluoroscopic visualization. Flush catheters feature side-holes to disperse contrast for large area imaging (e.g., aorta, leg run-off); selective catheters target specific vascular areas. Used by physicians in clinical settings to provide a pathway for contrast media delivery. Benefits include enabling vascular imaging for diagnostic purposes.

Clinical Evidence

No clinical data; clinical evaluation was not required.

Technological Characteristics

Sterile, single-use diagnostic intravascular catheter; 4F and 5F diameters; 40-100 cm lengths; radiopaque distal segment; flush and selective configurations; side-holes on flush models. Sterilization process mentioned.

Indications for Use

Indicated for patients requiring delivery of contrast media to selected vascular sites, including carotid arteries, for diagnostic imaging.

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

• Imager II Angiographic Catheter (K050863)

Submission Summary (Full Text)

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K120893 page 1 of 1

MAR 2 9 2012

# 510(k) Summary per 21 CFR §807.92

| Sponsor: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick MA 01760 |
|-------------------|---------------------------------------------------------------------------------|
| Contact Person: | Anne Rossi |
| Phone Number: | 763-255-0681 |
| Fax Number: | 763-494-2222 |
| Prepared: | 22 March 2012 |
| Trade Name: | Imager™ II Angiographic Catheter |
| Common Name: | Diagnostic Intravascular Catheter |
| Classification: | II |
| Product Code: | DQO / 21 CFR 870.1200 |
| Predicate Device: | Imager II Angiographic Catheter (K050863; 02 September 2005) |

# Device Description:

The 4F and 5F Imager™ II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90 cm, and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, flush catheters are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.). Side-holes are added to disperse the contrast. Selective catheters are used to create images of specific areas of interest.

## Intended Use:

The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.

## Substantial Equivalence:

The modified Imager II Angiographic Catheter packaging configuration is substantially equivalent to the Imager II Angiographic Catheter (K050863, cleared 02 September 2005) packaging configuration.

## Summary of Non-Clinical Testing:

Design verification testing as listed below was performed to verify the performance of the Imager II Angiographic Catheter packaging after multiple sterilization, climatic conditioning and distribution simulation conditioning is substantially equivalent to the predicate device.

- � Visual Inspection
- � Dve Penetration Testing
- Peel Testing �
- � Catheter Removal Force Testing

# Summary of Clinical Testing:

Clinical Evaluation was not required for these devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 2 9 2012

Boston Scientific Corp. c/o Ms. Anne Rossi Manager, Regulatory Affairs One Scimed Place Maple Grove, MN 55311-1566

#### Re: K120893

Trade/Device Name: Imager II Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: 22 March, 2012 Received: 22 March, 2012

# Dear Ms. Rossi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Anne Rossi

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

C.M.A. Hillebrand

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

Enclosure

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# Indications for Use

510(k) Number (if known): K 120893

Device Name: IMAGER II Angiographic 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 including the carotid arteries.

Prescription Use × (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)

M.S. Hillelson

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K120893

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