COAXIAL DILATOR SET

K974640 · Boston Scientific Corp · DRE · Mar 13, 1998 · Cardiovascular

Device Facts

• Record ID: K974640
• Device Name: COAXIAL DILATOR SET
• Applicant: Boston Scientific Corp
• Product Code: DRE · Cardiovascular
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

The coaxial dilator is used for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a small 21 Ga. needle stick.

Device Story

Coaxial dilator set consists of inner tapered dilator and slightly shorter outer dilator. Used for percutaneous vascular access; facilitates introduction of 0.035 or 0.038 inch guide wires following 21 Ga. needle stick. Operated by clinicians in clinical settings. Device provides mechanical dilation of puncture site to allow wire placement. Benefits include simplified vascular access procedure.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Coaxial dilator set comprising inner tapered dilator and outer dilator. Sterilized via ethylene oxide gas. Packaged in heat-sealed Tyvek/mylar pouch.

Indications for Use

Indicated for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a 21 Ga. needle stick.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Cook's Micropuncture Introducer Set
• Boston Scientific's peelable sheath and dilator

Submission Summary (Full Text)

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K9 74 642

# SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to \$513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

## A. GENERAL INFORMATION

| Owner Operator Submitting this Premarket Notification: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01757<br>[phone] | MAR 1 3 1998 |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Wanda M. Carpinella<br>Regulatory Affairs Department | |
| Device Generic Name: | Coaxial Dilator | |
| Device Classification: | 74 DRE, Dilator, Vessel for Percutaneous Catheterization | |

#### B. INDICATIONS FOR USE

The coaxial dilator is used for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a small 21 Ga. needle stick.

### C. DESCRIPTIVE CHARACTERISTICS

The coaxial dilator set consists of an inner, tapered dilator with a slightly shorter outer dilator.

#### D. SUBSTANTIAL EQUIVALENCE

The proposed coaxial dilator set has been shown to be substantially equivalent to the coaxial dilator provided in Cook's Micropuncture Introducer Set and to Boston Scientific's peelable sheath and dilator.

## E. PACKAGING, STERILIZATION, AND PYROGENICITY

The coaxial dilator set is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes.

#### F. CONCLUSION

. .

Based on the information presented, Boston Scientific Corporation believes that the proposed coaxial dilator set meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed coaxial dilators,

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR / 3 1998

Ms. Wanda M. Carpinella Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Re: K974640 Coaxial Dilator Set Requlatory Class: II (two) Product Code: 74 DRE Dated: December 11, 1997 December 15, 1997 Received:

Dear Ms. Carpinella:

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

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#### Page 2 - Ms. Wanda M. Carpinella

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" (21 CFR 807.97). Other general 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/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

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

Enclosure

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510(k) Number (if known):

New Application

Device Name:

Coaxial Dilator Set

The coaxial dilator set is used for percutaneous Indications for Use: introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a 21 Ga. needle stick.

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

Concurrence of CDRH, Office of Device Evaluaiton (ODE)

Dan A. R.

(Division Sign-Om)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K974640

Prescription Use (Per 21 CRF 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)