IMPULSE AND EXPO ANGIOGRAPHIC CATHETER

K120495 · Boston Scientific Corp · DQO · May 21, 2012 · Cardiovascular

Device Facts

• Record ID: K120495
• Device Name: IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
• Applicant: Boston Scientific Corp
• Product Code: DQO · Cardiovascular
• Decision Date: May 21, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Impulse™ and Expo™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

Device Story

Impulse™ and Expo™ Angiographic Catheters are single-lumen diagnostic intravascular guide catheters; available in 5F and 6F sizes; models include Selective, Pigtail, and Multi-Purpose. Device construction features multiple polymer layers with an embedded stainless steel braid; atraumatic tip lacks braid; proximal end includes insert-molded polymer hub and strain relief. Used by physicians in clinical settings during angiographic procedures to provide a pathway for contrast media delivery to vascular sites. Device facilitates visualization of the vascular system via contrast media injection, aiding clinical diagnosis and decision-making.

Clinical Evidence

No clinical data. Bench testing only, including shaft stiffness, tip bond tensile strength, shaft integrity (burst pressure), hub tensile strength, radiopacity, and biocompatibility (cytotoxicity, hemolysis, FTIR, latex).

Technological Characteristics

Single-lumen catheter; 5F and 6F sizes; multi-layer polymer construction with embedded stainless steel braid; atraumatic tip; insert-molded polymer hub and strain relief. Non-active device. Sterilization and packaging methods utilized.

Indications for Use

Indicated for use in patients undergoing angiographic procedures requiring a pathway for the delivery of 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

• Impulse (K964859)
• Impulse (K974559)
• Expo (K934581)
• Expo (K934541)

Submission Summary (Full Text)

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K120495
p. 1 of 1

MAY 2 1 2012

## 510(k) Summary

per 21 CFR §807.92

| Sponsor: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick MA 01760 |
|-------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yumi Wackerfuss |
| Phone Number: | 763-255-0785 |
| Fax Number: | 763-494-2222 |
| Prepared: | 16 February 2012 |
| Trade Name: | Impulse™ and Expo™ Angiographic Catheter |
| Common Name: | Diagnostic Intravascular Guide Catheter |
| Classification: | II |
| Product Code: | DQO, 21 CFR 870.1200 |
| Predicate Device: | Impulse: K964859 (10 Feb 1997), K974559 (23 Feb 1998)<br>Expo: K934581 (13 March 1994), K934541 (12 May 1994) |

### Device Description

The Impulse™ and Expo™ Angiographic Catheters are single lumen catheters offered in Selective, Pigtail and Multi-Purpose models in 5F and 6F. The devices have multiple polymer layers with a stainless steel braid embedded between the layers. The atraumatic tip does not contain braid. The proximal end consist of an insert molded polymer hub and a strain relief.

#### Intended Use

The Impulse™ and Expo™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

### Substantial Equivalence

Modified Impulse™ and Expo™ Angiographic Catheter designs, materials, manufacturing processes and intended use are substantially equivalent to the predicate Impulse™ and Expo™ Angiographic Catheters.

### Summary of Non-Clinical Testing

Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices. Biocompatibility, sterility, and packaging testing were also performed to verify the overall safety and efficacy of the device.

Specifically the following design verification was performed:

- . Shaft Stiffness
.

- · · · · · · · · · · · · · Biocompatibility Testing ·
- Tip Bond Tensile Strength
- Shaft Integrity: Burst Pressure .
- . Hub Tensile
- Radiopacity .
- - > Cytotoxicity
- > Hemolysis
- 本 FTIR
- 公 Latex

### Summary of Clinical Testing

Clinical Evaluation was not required for these devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

#### Public Health Service

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

MAY 2 1 2012

Boston Scientific Corporation c/o Ms. Yumi Wackerfuss Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K120495

Trade/Device Name: Impulse and Expo Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: April 3, 2012 Received: April 4, 2012

Dear Ms. Wackerfuss:

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. Yumi Wackerfuss

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/CDRH/CDRHOffices/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,

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 Form

510(k) Number (if known):

Device Name: Impulse™ and Expo™ Angiographic Catheter___

Indications for Use:

The Impulse™ and Expo™Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Burision Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120495

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