OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER

K082646 · Usci Ireland · DQY · Nov 3, 2008 · Cardiovascular

Device Facts

• Record ID: K082646
• Device Name: OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
• Applicant: Usci Ireland
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 3, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Two-lumen catheter with distal inflatable balloon; one lumen for contrast medium inflation, one for guidewire advancement. Two radiopaque marker bands indicate balloon dilatating section and nominal length. Designed for entry into arteries and crossing tight stenoses. Used by physicians in clinical settings for percutaneous transluminal angioplasty (PTA). Device facilitates vessel patency by dilating stenotic regions.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 Part 1.

Technological Characteristics

Two-lumen catheter; distal inflatable balloon; radiopaque marker bands. Biocompatible materials per ISO 10993-1. Mechanical dilation principle.

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

• OPTIMUS 0.035" PTA Balloon Dilatation Catheter (K072156)
• Cordis OPTA PRO PTA Catheter (K032737)
• Invatec SAILOR PLUS PTA Catheter (K042538)

Submission Summary (Full Text)

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K082646 page 1 of 3

# USCI Ireland NOV - 3 2008 Universal Sciences Catheters & Instruments

## 2.5 510(k) Summary

# OPTIMUS 0.035" PTA Balloon Dilatation Catheter

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

# 2.5.1

# General Information

Submitter:

Telephone Number:

Fax Number:

Contact Person:

Summary Preparation Date:

## 2.5.2 Device Information

Device Name:

Common Name:

Classification Name:

USCI Ireland IDA Business Park, Ballinasloe, Co. Galway, Ireland

011 353 909 646300

011 353 909 646330

Ailish O'Reilly

September 4th 2008

OPTIMUS 0.035" PTA Balloon Dilatation Catheter

PTA Balloon Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250, Product Code: DQY)

## 2.5.3 Predicate Devices

Device Name:

510(k) Clearance Number:

Device Name:

510(k) Clearance Number:

Device Name:

510(k) Clearance Number:

OPTIMUS 0.035" PTA Balloon Dilatation Catheter

K072156

Cordis OPTA PRO PTA Catheter

K032737

Invatec SAILOR PLUS PTA Catheter

K042538

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

CONFIDENTIAL

Page 4 of 97

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# USCI) USCI Ireland Universal Sciences Catheters & Instruments

## 2.5.4 Device Description

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 marker bands 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.

## 2.5.5 Indications for Use

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

### 2.5.6 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 was determined to be biocompatible.

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/11 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 logo. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2008

Complete Comments of the Comments of Children and Children Comments of Children of Children

USCI Ireland c/o Ms. Ailish O'Reilly IDA Business Park Ballinasloc Co. Galway Ireland

Re: K082646

OPTIMUS 0.035" PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (2) Product Code: DQY Dated: October 2, 2008 Received: October 7, 2008

Dear Ms. O'Reilly:

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. Ailish O'Reilly

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 prodicate device results in a classification for your device and thus, permits your device to proceed to the market.

പ്രത്തേത്തിന് വിക്കുന്നതിനു പ്രാമ്പ്യക്ഷേത്രിൽ തിരിച്ച് നിന്നും എന്ന ക്ഷേത്രത്തിനായ വേണ്ടി വിശ്വീനിക്കുന്നതിന്റെ എക്കുകയുടെ

If you desire spccific 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 Biometrics' (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,

Duna R. Holmes

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: K082646

Device Name: OPTIMUS 0.035" PTA Balloon Dilatation Catheter

ച്ചത്തിന് അവലംബം പ്രസിഡ് എന്നിവ് എന്നിവിടങ്ങി നിന്നും പ്രകൃത്തിന്റെ സമ്പേഷ് ക്രിക്കുന്നതാണ് അവലംബം സ്ഥിച്ചിരിക്കുന്നത്.

Indications for Use:

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

Prescription Use & (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)

Page 1 of 1

Duna R. Lo liner
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_≤08264

CONFIDENTIAL

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