BANTAM,48XXXXXX, 50XXXXXX

K093139 · ClearStream Technologies , Ltd. · LIT · Dec 30, 2009 · Cardiovascular

Device Facts

• Record ID: K093139
• Device Name: BANTAM,48XXXXXX, 50XXXXXX
• Applicant: ClearStream Technologies , Ltd.
• Product Code: LIT · Cardiovascular
• Decision Date: Dec 30, 2009
• Decision: SESE
• Submission Type: Special
• 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

Bantam and Bantam a PTA catheters are over-the-wire (OTW) percutaneous catheters used for balloon dilatation of peripheral arteries. The device features a co-axial design with a balloon at the distal tip. One lumen facilitates balloon inflation, while the internal lumen allows for guidewire insertion (max 0.018" or 0.014"). Operated by physicians in clinical settings, the catheter is advanced over a guidewire to the target lesion; the balloon is then inflated to a specific pressure to achieve dilatation. The device provides mechanical expansion of stenotic vessels to improve blood flow. No electronic or software components are involved.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated through non-clinical design verification and validation tests and analyses.

Technological Characteristics

Co-axial over-the-wire (OTW) catheter; balloon distal tip; inflation lumen and guidewire lumen (0.014"/0.018" compatibility); mechanical expansion via inflation pressure. No electronic, software, or energy-based components.

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

• Savvy Long PTA Catheter (K072947)

Submission Summary (Full Text)

{0}------------------------------------------------

Special 510(k) Submission - ClearStream Technologies Ltd

# 510(k) Summary

K093139

## Applicant Information

Date Prepared: September 18th 2009 Submitter: ClearStream Technologies Ltd

DEC 3 0 2009

Address: Moyne Upper, Enniscorthy, Co.Wexford, Ireland.

Establishment Registration No: 9616666

Contact Person: Fiona Ni Mhullain, RA Manager

Telephone Number: [phone] Fax Number: + 353 (0) 53 9237100

#### Device Information

Trade Name: Bantam and Bantam a PTA Catheter Common Name: OTW PTA Catheter Classification Name: Percutaneous Catheter Classification: Class II, 21 CFR 870.1250 Product Code: DQY

### Predicate Device:

ClearStream Technologies Ltd, proposes its Savvy Long PTA Catheter cleared through the following 510(k) number submission: K072947, as the predicate device for this submission.

## Device Description:

The Bantam and Bantam & PTA Catheters are standard over-the-wire PTA catheters. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows

{1}------------------------------------------------

access to the distal tip of the catheter for guidewire insertion (max 0.018" and 0.014"). The balloon expands to a known diameter at specific pressure.

# 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:

The ClearStream Technologies Ltd Bantam and Bantam a PTA catheter is substantially equivalent to the predicate device The Savvy Long PTA Catheter.

# Test Data:

The safety and effectiveness of the ClearStream Bantam and Bantam & PTA Catheter has been demonstrated through data collected from non-clinical design verification and design validation tests and analyses.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, symbolizing protection and care. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

ClearStream Technologies Ltd. c/o Ms. Fiona Ni Mhullain Moyne Upper Enniscorthy, Ireland

DEC 30 2009

Re: K093139

Trade/Device Name: Bantam and Bantam a OTW PTA Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: November 26, 2009 Received: November 30, 2009

Dear Ms. Mhullain:

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 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.

{3}------------------------------------------------

Page 2 - Ms. Fiona Ni Mhullain

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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

Enclosure

{4}------------------------------------------------

. Special 510(k) Submission – ClearStream Technologies Ltd

Indications for Use

510(k) Number (if known):

): L093139

Device Name: Bantam and Bantam a OTW 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 anteries.

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

A.W.C.

(Division Sign-Off) Division of Cardiovascuten Devices

510(k) Number