OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER

K981407 · Cordis Corp. · LIT · May 20, 1998 · Cardiovascular

Device Facts

• Record ID: K981407
• Device Name: OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
• Applicant: Cordis Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opta LP and Powerflex Plus PTA Balloon Catheters are intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Dual-lumen PTA balloon catheter; distal inflatable balloon; two radiopaque marker bands for positioning. Used by physicians in clinical settings to dilate arterial stenoses or arteriovenous dialysis fistulae. Guidewire lumen allows tracking over prepositioned guidewire or injection of contrast medium/saline. Inflation lumen used for balloon expansion. Radiopaque markers indicate balloon length and placement. Benefits include restoration of vessel patency in peripheral vasculature and dialysis access sites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-lumen catheter design; distal inflatable balloon; radiopaque marker bands; guidewire lumen compatible with contrast/saline injection (max 150 psi).

Indications for Use

Indicated for dilation of stenoses in iliac, femoral, ilio-femoral, 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 Opta LP PTA Balloon Catheter
• Cordis Powerflex Plus PTA Balloon Catheter
• Cordis Opta5 PTA Balloon Catheter
• Cordis Powerflex PTA Balloon Catheter

Submission Summary (Full Text)

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K981407

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1.2.

| MAY 20 1998 | Summary of Safety and Effectiveness |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Trade Name: Opta LP PTA Balloon Catheter<br>Powerflex Plus PTA Balloon Catheter |
| | Common/Classification Name: Peripheral Transluminal Angioplasty Balloon<br>Catheter |
| Name of<br>Predicate<br>Devices | Cordis Opta LP PTA Balloon Catheter<br>Cordis Powerflex Plus PTA Balloon Catheter<br>Cordis Opta5 PTA Balloon Catheter<br>Cordis Powerflex PTA Balloon Catheter |
| Classification | Class II. |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Food, Drug and Cosmetic Act. |
| Intended Use<br>and Device<br>Description | The Opta LP and Powerflex Plus PTA Balloon Catheters are intended to<br>dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and<br>renal arteries and, for the treatment of obstructive lesions of native or<br>synthetic arteriovenous dialysis fistulae. |
| | The Opta LP and Powerflex Plus PTA Balloon Catheters have a dual lumen<br>design with distal inflatable balloon. Two radiopaque marker bands indicate<br>the dilating section of the balloon and aid in balloon placement. |
| | All balloons distend to sizes above the nominal size at pressures greater than<br>the nominal pressure. |
| | The balloon inflation lumen is used to inflate and deflate the balloon. The<br>nominal balloon size is printed on the hub. |
| | The guidewire lumen is used to track the catheter over a prepositioned<br>guidewire or to inject contrast medium and/or saline. The maximum injection<br>pressure is 150 psi. The compatible guidewire size, catheter shaft French size<br>and catheter length are printed on the hub. The radiopaque marker bands<br>indicate the stated nominal length of the balloon |

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Summary of Substantial Equivalence

The Opta LP and Powerflex Plus PTA Balloon Catheters described in this submission are similar in their basic design, construction, indications for use and performance characteristics to Opta LP, Powerflex Plus, Opta5 and Powerflex PTA catheters which previously received 510(k) concurrence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Mirjam Barboza, M.D. Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re: K981407 Trade Name: Cordis Opta LP PTA Balloon Catheter and Cordis Powerflex Plus PTA Balloon Catheter Regulatory Class: II Product Code: LIT Dated: April 17, 1998 Received: April 20, 1998

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 leqally 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 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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Page 2 - Dr. Barboza

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.

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"(21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

in and the same

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## Indications for Use Statement

| 510(k) Number<br>(if known) | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Cordis Powerflex Plus PTA Balloon Catheter |
| Indications for<br>Use | The Powerflex Plus PTA Balloon Catheter is indicated to dilate stenoses in<br>iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries, and for<br>treatment of obstructive lesions of native or synthetic arteriovenous dialysis<br>fistulae. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Turt. A. Q

(Division Sign-Off) Division of Cardiovascular, P and Neurological Devices 18/45/ 510(k) Number

Prescription Use _ (Per 21 CFR 801.109)

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OR

Over-The-Counter Use_