SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS

K072947 · ClearStream Technologies , Ltd. · LIT · Feb 8, 2008 · Cardiovascular

Device Facts

• Record ID: K072947
• Device Name: SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
• Applicant: ClearStream Technologies , Ltd.
• Product Code: LIT · Cardiovascular
• Decision Date: Feb 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

Device Story

Semi-compliant coaxial PTA catheter; features distal balloon and hub/Y-connector for guidewire tracking and balloon inflation; includes platinum-iridium radiopaque bands at balloon shoulders for fluoroscopic visualization; transparent hub facilitates air bubble observation and removal. Used by physicians in clinical settings for peripheral artery angioplasty. Device tracks over guidewire to lesion site; balloon inflated to dilate stenotic vessels; improves blood flow in peripheral vasculature.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Semi-compliant coaxial catheter design; platinum-iridium radiopaque marker bands; transparent hub for air bubble management; balloon inflation via port; guidewire compatible.

Indications for Use

Indicated for balloon dilatation of femoral, popliteal, and infra-popliteal arteries. Contraindicated for use in coronary 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

• Submarine Plus Percutaneous Transluminal Angioplasty (PTA) Catheters (K042537)

Submission Summary (Full Text)

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K072947 Page 1 of 1

# Premarket Notification - ClearStream Technologies PTA Catheters

#### 510(k) SUMMARY

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 8807.92.

### Submitter Information:

ClearStream Technologies Moyne Upper, Enniscorthy,Co. Wexford. Ireland

## Date Summary Prepared: January 3, 2008

## Contact Persons:

lan P Gordon Senior Vice President Emergo Group, Inc. 1705 S Capital of Texas Hwy Suite 500 Austin TX 78746 Fax [phone]

#### Device Name:

Trade Name(s): Savvy Long and Sleek Peripheral Transluminal Angioplasty (PTA) Catheters Classification Name: Percutaneous catheter Classification Regulation: 21 CFR 870.1250 Panel: Cardiovascular Product Code: LIT

#### Predicate Device Information:

Device Name: Submarine Plus Percutaneous Transluminal Angioplasty (PTA) Catheters Manufacturer: Invatec Innovative Technologies Reference: K042537

#### Device Description:

A family of semi-compliant coaxial design catheters in various sizes. Each catheter has a balloon mounted on its distal tip. A hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port used to inflate the balloon. To locate the balloon under fluoroscopy platinum iridium bands are provided at the shoulders of the balloon for all sizes. The proximal end of the catheter is provided with a transparent hub which allows easy observation of air bubbles. The hub is designed to facilitate easy removal of air bubbles during the preparation of the balloon.

#### Intended Use:

Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

#### Comparison to Predicate Device:

This device is equivalent to the predicate device in intended use, design characteristics, and general physical characteristics.

#### Testing and Conclusions:

Performance testing and compliance with recognized standards have established substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB - 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Clearstream Technologies, Ltd. c/o Mr. Ian Gordon Emergo Group, Inc. 1705 S. Capital of Texas Hwy, Suite 500 Austin, TX 78746

Re: K072947

Trade/Device Name: Savvy Long and Sleek PTA Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: January 8, 2008 Received: January 10, 2008

Dear Mr. Gordon:

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 - Mr. Ian Gordon

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,

Dma R. bochner

ABram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K072947

Device Name: ClearStream Technologies PTA Catheters

## Indications for Use:

Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

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

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

suma D. Valmes

(Division Sich-Off) Division or Cardiovascular Devices

710(k) Number_K072947