SCIMED ANGIOGRAPHIC CATHETERS

K992142 · Scimed · DQO · Jul 21, 1999 · Cardiovascular

Device Facts

• Record ID: K992142
• Device Name: SCIMED ANGIOGRAPHIC CATHETERS
• Applicant: Scimed
• Product Code: DQO · Cardiovascular
• Decision Date: Jul 21, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

SCIMED EXPO and Impulse 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

Diagnostic intravascular catheter; provides pathway for contrast media delivery to vascular sites during angiography. Device modification involves change in hub material. Used by physicians in clinical settings. Output is delivery of contrast media to facilitate imaging. Benefits include maintaining established clinical utility of SCIMED EXPO and Impulse catheter lines with updated material.

Clinical Evidence

No clinical data. Bench testing only; functional testing performed to verify integrity of modified hub and biocompatibility testing performed on new hub material.

Technological Characteristics

Diagnostic intravascular catheter. Modification limited to hub material. Functional and biocompatibility testing performed. No changes to device dimensions, sensing, energy source, or software.

Indications for Use

Indicated for use as a pathway for delivering contrast media to selected sites in the vascular system during angiographic procedures.

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

• SCIMED® EXPO and Impulse Angiographic Catheters (K992142)

Submission Summary (Full Text)

{0}------------------------------------------------

K992M2

#### JUL 2 1 ਰਿਰੋਰੇ Special 510(k) : Device Modification SCIMED Angiographic Catheters Hub Material Change

# Section 4

# Summary of Safety and Effectiveness

.. ...

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

### I. General Provisions

| Submitter's Name<br>and Address | Boston Scientific SCIMED, Inc.<br>One SCIMED Place<br>Maple Grove, Minnesota 55311 |
|---------------------------------|------------------------------------------------------------------------------------|
| Contact Person | Melanie Raska<br>[phone] |
| Classification Name | Diagnostic Intravascular Catheters<br>(21CFR Part 870.1200) |
| Common or Usual Name | Diagnostic Intravascular Catheter |
| Proprietary Name | SCIMED® EXPO and Impulse<br>Angiographic Catheters |
| Name of Predicate Devices | SCIMED® EXPO and Impulse<br>Angiographic Catheters |

### II. Device Description

The modified SCIMED EXPO and Impulse angiographic catheters are the same as the SCIMED EXPO and Impulse angiographic catheters currently on the market with the exception of the new hub material.

### III. Intended Use

SCIMED EXPO and Impulse 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.

#### IV. Summary of Technological Characteristics

Same as currently marketed EXPO and Impulse angiographic catheters.

#### V. Non-clinical Test Summary

Functional testing was conducted to verify the integrity of the modified hub. Biocompatibility testing was conducted on the new hub material.

{1}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 1999

Ms. Melanie Raska Regulatory Affairs Specialist Boston Scientific SCIMED, Inc. One Scimed Place Maple Grove, MN 55311-1566

Re: K992142 SCIMED EXPO and Impulse Angiographic Catheters Trade Name: Requlatory Class: II Product Code: DQO Dated: June 23, 1999 June 24, 1999 Received:

Dear Ms. Raska:

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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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

{2}------------------------------------------------

Page 2 - Ms. Melanie Raska

you might 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 advertisinq 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 qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callshan

Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Special 510(k) : Device Modification SCIMED Angiographic Catheters Hub Material Change

### Section 3

Indications for Use

510(k) Number (if known)

Device Name: SCIMED® EXPO and Impulse Angiographic Catheters

Indications for Use:

The SCIMED EXPO and Impulse 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_*** OR Over The Counter Use **_**
(Per 21 CFR 801.109)

(Division Sign Off) (Optional Format 1-2-96)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number K99 2142