OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER

K072156 · Usci Ireland · DQY · Nov 9, 2007 · Cardiovascular

Device Facts

• Record ID: K072156
• Device Name: OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER
• Applicant: Usci Ireland
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Iliac, Femoral, Popliteal and Renal arteries.

Device Story

The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two-lumen catheter used for percutaneous transluminal angioplasty. One lumen facilitates balloon inflation with contrast medium; the second lumen accommodates a guide wire for navigation to and through arterial stenoses. Two radiopaque marker bands identify the balloon's dilating section and aid in precise placement. The catheter tip is designed to facilitate entry into arteries and crossing of tight stenoses. Used by physicians in clinical settings, the device enables mechanical dilation of narrowed vessels, potentially improving blood flow and patient outcomes. Safety and effectiveness are established through design verification and biocompatibility testing.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through non-clinical design verification and validation testing, including biocompatibility testing per ISO 10993 Part 1.

Technological Characteristics

Two-lumen catheter design; distal inflatable balloon; radiopaque marker bands for positioning; compatible with 0.035" guide wires. Biocompatibility per ISO 10993 Part 1. No software or electronic components.

Indications for Use

Indicated for patients requiring dilation of stenoses in the Iliac, Femoral, Popliteal, and Renal arteries.

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 PRO PTA Catheter (K032737)

Submission Summary (Full Text)

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# USCI Ireland Universal Sciences Catheters & Instruments

### 2.5 510(k) Summary

OPTIMUS 0.035" PTA Balloon Dilatation Catheter

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 1. General Information

| Submitter: | USCI Ireland<br>IDA Business Park,<br>Ballinasloe,<br>Co. Galway,<br>Ireland | NOV 0 9 2007 |
|---------------------------|-----------------------------------------------------------------------------------------|--------------|
| Telephone Number: | 011 353 909 646300 | |
| Fax Number: | 011 353 909 646330 | |
| Contact Person: | Denise Kennedy | |
| Summary Preparation Date: | 1st August 2007 | |
| 2. | Device Information | |
| Device Name: | OPTIMUS 0.035" PTA Balloon Dilatation<br>Catheter | |
| Common Name: | PTA Balloon Dilatation Catheter | |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal<br>(21 CFR 870.1250, Product Code: DQY) | |
| 3. | Predicate Devices | |
| Device Name: | Cordis OPTA PRO PTA Catheter | |

K032737 510(k) Clearance Number:

This Premarket Notification (510(k) submission) aims to demonstrate "substantial equivalence (SE)" of the USCI OPTIMUS 0.035" PTA Balloon Dilatation Catheter through comparison with the "predicate device" - Cordis OPTA PRO. The Substantial Equivalence discussion is documented in section 2.12. Substantial equivalence (SE) is demonstrated within the "intended use" of the OPTIMUS device. Where SE is not directly demonstrated from the perspective of technology and performance, design verification testing provides evidence of the safety and effectiveness of the OPTIMUS device. The design verification testing is detailed in section 2.18 of this submission - Performance Testing.

### 4. Device Description

USCI Ireland IDA Business Park, Ballinasloe, Co Galway, Ireland VAT: 9989802K

CONFIDENTIAL

K072156 p. L of 2

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## USCI Ireland Universal Sciences Catheters & Instruments

The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque markerbands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.

### 5. Indications for Use

The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Iliac, Femoral, Popliteal and Renal arteries.

## 6. Performance Data

Substantial equivalence of the OPTIMUS 0.035" PTA Balloon Dilatation Catheter to the predicate device has been demonstrated through data collected from non-clinical design verification/ validation tests and analyses. The device has been tested according to ISO 10993 Part 1 and has been determined to be biocompatible.

:

USCI Ireland IDA Business Park, Ballinasloe, Co Galway, Ireland VAT: 9989802K

. . . . .

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2002

USCI Ireland c/o Ms. Denise Kennedy Senior DA & RA Engineer IDA Business Park Ballinasloe, Co Galway, Ireland

Re: K072156 Optimus 0.035" PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (Two) Product Code: DQY Dated: October 09, 2007 Received: October 10, 2007

Dear Ms. Kennedy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Denise Kennedy

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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Durna R. Lochner

( J 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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#### 2.4 Indications for Use

510(k) Number: K072156

Device Name: OPTIMUS 0.035" PTA Balloon Dilatation Catheter

Indications for Use:

The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.

Prescription Use 区 (Part 21 CFR 801 Subpart D)

..

And/ Or

Over-The- Counter Use [] (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(K) Number Ko 77 150

CONFIDENTIAL

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