LITEPAC, MODEL 682

K100490 · ClearStream Technologies , Ltd. · LIT · Mar 16, 2010 · Cardiovascular

Device Facts

• Record ID: K100490
• Device Name: LITEPAC, MODEL 682
• Applicant: ClearStream Technologies , Ltd.
• Product Code: LIT · Cardiovascular
• Decision Date: Mar 16, 2010
• 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

LitePAC PTA Catheter is a rapid exchange percutaneous transluminal angioplasty (PTA) catheter; used for balloon dilatation of peripheral arteries. Device features proximal mono luer hub for inflation/deflation via outer lumen; rapid exchange port at transition between stiff hypotube and flexible distal portion allows single-operator use with 0.014" guidewire. Operated by physicians in clinical settings; device facilitates vessel opening by inflating balloon to dilate femoral, popliteal, or infra-popliteal arteries. Output is mechanical expansion of arterial lumen; aids in restoring blood flow.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness demonstrated via in vitro testing including visual/functional testing, catheter body diameter, balloon working surface, inflation/deflation, pull back, balloon compliance, average burst pressure, and tensile testing of proximal bond, in compliance with ISO 10555-1 and ISO 10555-4.

Technological Characteristics

Rapid exchange PTA catheter; includes hypotube and flexible distal portion. Materials and design comply with ISO 10555-1 and ISO 10555-4. Features mono luer hub for inflation/deflation. Compatible with 0.014" guidewire. Mechanical device; no software or electronic 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

• Sleek PTA Catheter (K072947)

Submission Summary (Full Text)

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K100490 page 1 of 3

Special 510(k) Submission - ClearStream Technologies Ltd

# 510(k) Summary

# Applicant Information

# MAR 1 6 2010

Date Prepared: February 10th 2010 Submitter: ClearStream Technologies Ltd

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: LitePAC PTA Catheter Common Name: RX PTA Catheter Classification Name: Percutaneous Catheter Classification: Class II, 21 CFR 870.1250 Product Code: DQY

#### Predicate Device:

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

#### Device Description:

The LitePAC PTA Catheter is a standard rapid exchange PTA catheter. The proximal end provides a mono luer hub connector which allows the

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K100490 page 2 of 3

Special 510(k) Submission - ClearStream Technologies Ltd

attachment of an inflation device used to inflate and deflate the balloon through the outer lumen.

The rapid exchange port is positioned at the transition area between the stiffer hypotube and the more flexible distal portion and facilitates single operator use for insertion into a 0.014" guidewire.

# 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 LitePAC catheter (K100490) is substantially equivalent to the predicate device The Sleek PTA Catheter (K072947).

# Test Data:

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

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clearStream
Technologies Ltd

Special 510(k)

LitePAC

# Brief Comparison Summary

To demonstrate substantial equivalence of the applicant LitePAC PTA catheter to the predicate devices, the technological characteristics and performance criterion were evaluated using in vitro testing performed as outlined below:

# In Vitro Testing

Using FDA guidance documents on non-clinical testing of medical devices the following in vitro tests were performed:

- Visual and functional testing
- Catheter body diameter .
- Measurement of balloon working surface
- Inflation/deflation testing .
- Pull back testing .
- Balloon Compliance .
- Average burst pressure
- Tensile testing of proximal bond

Testing was also performed in compliance with ISO 10555-1 and ISO 10555-4.

The results from the tests demonstrate that the technological characteristics and performance criteria of the LitePAC PTA catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

# Conclusion

ClearStream Technologies Ltd believes that the data and information presented in this application, including in vitro testing and numerous device similarities support a determination of substantial equivalence, and therefore market clearance of the LitePAC PTA catheter through this 510(k) premarket notification.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# MAR 1 6 2010

ClearStream Technologies, Ltd. c/o Fiona Ni Mhullain, Regulatory Affairs Manager Moyne Upper, Enniscorthy County Wexford Ireland

Re: K100490

Trade/Device Name: LitePAC PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT, DOY Dated: January 16, 2010 Received: February 19, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Duma R. Lahner

Image /page/4/Picture/8 description: The image shows a handwritten symbol that resembles a cursive letter 'f' with an additional loop at the top. The symbol is drawn in black ink on a white background. The stroke begins with a curved line extending upwards, then loops back down before continuing into the main body of the 'f'. The overall impression is that of a quick, stylized signature or notation.

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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page 1 of 1

Special 510(k) Submission - ClearStream Technologies Ltd

#### Indications for Use

510(k) Number (if known): K100490

Device Name: LitePAC RX 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 Over-The-Counter Use (Part 21 CFR 801 Subpart. AND/OR (21 CFR 801 Subpart C) D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

... . . . . . . . . . . . . . . . . . . ..

Duna R. Holmes
Division Sign Off

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k100490