CORDIS OPTA LP PTA BALLOON CATHETER

K971448 · Cordis Corp. · LIT · Jul 3, 1997 · Cardiovascular

Device Facts

• Record ID: K971448
• Device Name: CORDIS OPTA LP PTA BALLOON CATHETER
• Applicant: Cordis Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opta LP PTA balloon catheters is intended to dilate stemoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Dual-lumen PTA balloon catheter; features distal inflatable balloon and two radiopaque marker bands for placement. Guidewire lumen allows tracking over prepositioned guidewire or injection of contrast/saline. Operated by clinicians in interventional settings. Inflation lumen used for balloon expansion within target vasculature. Radiopaque markers indicate dilating section. Device facilitates vessel dilation to treat stenoses and obstructive lesions. Benefits include restoration of blood flow in peripheral arteries and dialysis access sites.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and performance characteristics.

Technological Characteristics

Dual-lumen catheter design; distal inflatable balloon; radiopaque marker bands; guidewire lumen; biocompatible materials. Mechanical operation via inflation/deflation of balloon. No software or electronic components.

Indications for Use

Indicated for dilation of stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Cordis Opta5 PTA Balloon Catheter
• Cordis PowerFlex PTA Balloon Catheter
• Cordis Small Vessel PTA Balloon Catheter
• Cordis Savvy PTA Balloon Catheter
• Meditech UltraThin Balloon Catheter

Submission Summary (Full Text)

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### SUMMARY OF SAFETY EFFECTIVENESS

#### " 3 1997 . || ||

#### I. General Provisions

PTA Balloon Catheter Common or Usual Name:

Opta LP™ PTA Balloon Catheter Proprietary Name:

### II. Name of Predicate Devices

- Cordis Opta5 PTA Balloon Catheter
- Cordis PowerFlex PTA Balloon Catheter
- Cordis Small Vessel PTA Balloon Catheter
- Cordis Savvy PTA Balloon Catheter
- Meditech UltraThin Balloon Catheter

#### III. Classification

Class II

#### IV. Performance Standards

Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.

#### V. Intended Use and Device Description

The Opta LP PTA balloon catheters is intended to dilate stemoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Cordis Opta LP PTA balloon catheter is a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.

The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure.

The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub.

The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 450 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon.

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## VI. Biocompatibility

All materials used in the Opta LP PTA balloon catheter are biocompatible.

# VII. Summary of Substantial Equivalence

The Cordis Opta LP PTA balloon catheter and the referenced Cordis Opta5 PTA balloon catheter, Cordis PowerFlex PTA balloon catheter, Cordis Small Vessel PTA balloon catheter, Cordis Savvy PTA balloon catheter and Meditech UltraThin balloon catheter are similar in their basic design, construction, indication for use and performance characteristics.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mirjam Barboza, M.D. Manager, Requlatory Affairs and Clinical Research Cordis Corporation P.O. Box 025700. - -----------------------------------------------------------------------------------------------------------------------------------------------------------

K971448 Re : Cordis Opta™ LP PTA Balloon Catheter Regulatory Class: II (two) Product Code: LIT Dated: April 18, 1997 Received: April 21, 1997

Dear Dr. Barboza:

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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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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 witro. ... 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. Callehan

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):

Device Name: Cordis Opta LPTM PTA Balloon Catheter

Indications for Use:

The Opta LP PTA Balloon Catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Tara t. Rh

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use ------

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