SLEEK OTW PTA CATHETERS

{0}------------------------------------------------ Special 510(k) Submission - ClearStream Technologies Ltd # 510(k) Summary Technologies Ltd K102035 DEC 1 2010 ## Applicant Information Date Prepared: September 8th 2010 Submitter: ClearStream Technologies Ltd Address: Moyne Upper, Enniscorthy, Co.Wexford, Ireland. Establishment Registration No: 9616666 Contact Person: Fiona Ní Mhulláin, RA Manager Telephone Number: +353 (0) 53 9237111 Fax Number: + 353 (0) 53 9237100 Device Information Trade Name: Sleek OTW PTA Catheter Common Name: OTW PTA Catheter Classification Name: Percutaneous Catheter Classification: Class II, 21 CFR 870.1250 Product Code: LIT #### Predicate Device: ClearStream Technologies Ltd, proposes its Bantam a PTA Catheter cleared through the following 510(k) number submission: K093139, as the predicate device for this submission. ## Device Description: The Sleek OTW PTA Catheter is a standard over-the-wire PTA catheter. 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 access to the distal {1}------------------------------------------------ tip of the catheter for guidewire insertion (0.014"). The balloon expands to a known diameter at specific pressure. # Raw Materials | Materials | Usage | |----------------------------------|----------------------------------------------| | Pebax | Bridge tubing | | Co-extruded Nylon/Pebax | Shaft Inner Material | | Blue colorant | Colorant for Inner tube | | Nylon/ Pebax blend | Balloon tubing | | Platinum / Iridium band | Marker band | | Nylon / Pebax Blend | Shaft Outer Material:<br>1.25mm & 1.5mmx15mm | | Nylon blend | 1.5mmx20mm - 5.0mmx120mm | | Loctite | Hub bond.glue | | Pebax | Strain Relief | | Polycarbonate | Y- Connector | | Polycarbonate | Luer hub | | Nylon/Pebax Blend | Reinforcement Material | | Teflon | Balloon Sleeve | | Stainless steel | Flexible Shipping mandrel | | Domino Amjet Ink | Print on hub and strain relief | | Silicon | SiLX coating | | HDPE | Hoop | | Polyester / Polyethylene / Tyvek | Pouch | {2}------------------------------------------------ # The Product Specifications of the Sleek OTW PTA Catheter is as follows: | Balloon | | |--------------------------------------------------|--------------------------------------------------------------| | Nominal pressure | 6Atm | | Rated burst pressure 1.25mm and 1.5mm by 15 mm | 14Atm | | Rated burst pressure 1.5mm by 20-220mm | 16Atm | | Rated burst pressure 2.0-4.0mm by 20-40mm | 16Atm | | Rated burst pressure 5.0mm by 20-60mm | 14Atm | | Rated burst pressure 2.0 - 4.0mm by 80 - 220mm | 15Atm | | Rated burst pressure 5.0mm by 80-220mm | 13Atm | | Average burst pressure 1.25mm by 15 mm | 23Atm | | Average burst pressure 1.5mm by 15 mm | 21Atm | | Average burst pressure 1.5mm by 20-220mm | 22Atm | | Average burst pressure 2.0 - 4.0mm by 20 - 40mm | 22Atm | | Average burst pressure 5.0mm by 20-40mm | 20Atm | | Average burst pressure 2.0 - 4.0mm by 80 - 220mm | 21Atm | | Average burst pressure 5.0mm by 80-220mm | 19Atm | | Average compliance 1.25mm and 1.50mm | 10% ± 4% | | Average compliance | 8% ± 4% | | Deflation time | < 45 Secs | | Fold | Trifold with memory for 2.5 - 5.0mm, bifold for 1.25 - 2.0mm | | Tip lead in profile | <0.018" - 0.021" sliding scale by balloon diameter | | Sheath Compatibility 1.5mm - 5.0mm | 4F | | Shaft | | | Overall catheter length | 100, 130 and 150cm | | Shaft Format | Co-axial | | Guidewire Max. wire diameter | 0.014" | | Shaft Outer Diameter | 2.5F/3.2F (1.25 and 1.5)<br>2.8F/3.6F (other sizes) | | Hub | Polycarbonate with dual standard luer fittings | | Marker Bands | Platinum marker bands | {3}------------------------------------------------ # Catalogue number of the Sleek OTW | Catheter<br>Length<br>100cm | Balloon Lengths (mm) | | | | | | | |---------------------------------|----------------------|---------------|---------------|---------------|---------------|---------------|---------------| | Inflated<br>Balloon<br>Diameter | 20 | 40 | 80 | 100 | 120 | 150 | 220 | | 1.5 | 426-<br>1502L | 426-<br>1504L | 426-<br>1508L | 426-<br>1510L | 426-<br>1512L | - | - | | 2.0 | - | 426-<br>2004L | 426-<br>2008L | 426-<br>2010L | 426-<br>2012L | 426-<br>2015L | 426-<br>2022L | | 2.5 | - | 426-<br>2504L | 426-<br>2508L | 426-<br>2510L | 426-<br>2512L | 426-<br>2515L | 426-<br>2522L | | 3.0 | - | 426-<br>3004L | 426-<br>3008L | 426-<br>3010L | 426-<br>3012L | 426-<br>3015L | 426-<br>3022L | | 3.5 | - | 426-<br>3504L | 426-<br>3508L | 426-<br>3510L | 426-<br>3512L | - | - | | 4.0 | - | 426-<br>4004L | 426-<br>4008L | 426-<br>4010L | 426-<br>4012L | - | - | | 5.0 | - | 426-<br>5004L | 426-<br>5008L | 426-<br>5010L | 426-<br>5012L | - | - | | Catheter<br>Length<br>130cm<br>Inflated<br>Balloon<br>Diameter | Balloon Lengths (mm) | | | | | | | |----------------------------------------------------------------|----------------------|---------------|---------------|---------------|---------------|---------------|---------------| | | 20 | 40 | 80 | 100 | 120 | 150 | 220 | | 1.5 | 426-<br>1502W | 426-<br>1504W | 426-<br>1508W | 426-<br>1510W | 426-<br>1512W | - | - | | 2.0 | - | 426-<br>2004W | 426-<br>2008W | 426-<br>2010W | 426-<br>2012W | 426-<br>2015W | 426-<br>2022W | | 2.5 | - | 426-<br>2504W | 426-<br>2508W | 426-<br>2510W | 426-<br>2512W | 426-<br>2515W | 426-<br>2522W | | 3.0 | - | 426-<br>3004W | 426-<br>3008W | 426-<br>3010W | 426-<br>3012W | 426-<br>3015W | 426-<br>3022W | | 3.5 | - | 426-<br>3504W | 426-<br>3508W | 426-<br>3510W | 426-<br>3512W | - | - | | 4.0 | - | 426-<br>4004W | 426-<br>4008W | 426-<br>4010W | 426-<br>4012W | - | - | | 5.0 | - | 426-<br>5004W | 426-<br>5008W | 426-<br>5010W | 426-<br>5012W | - | - | {4}------------------------------------------------ | Catheter<br>Length<br>150cm | Balloon Lengths (mm) | | | | | | | | |---------------------------------|----------------------|---------------|---------------|---------------|---------------|---------------|---------------|---------------| | Inflated<br>Balloon<br>Diameter | 15 | 20 | 40 | 80 | 100 | 120 | 150 | 220 | | 1.25 | 426-<br>1201X | - | - | - | - | - | - | - | | 1.5 | 426-<br>1501X | 426-<br>1502X | 426-<br>1504X | 426-<br>1508X | 426-<br>1510X | 426-<br>1512X | - | - | | 2.0 | - | - | 426-<br>2004X | 426-<br>2008X | 426-<br>2010X | 426-<br>2012X | 426-<br>2015X | 426-<br>2022X | | 2.5 | - | - | 426-<br>2504X | 426-<br>2508X | 426-<br>2510X | 426-<br>2512X | 426-<br>2515X | 426-<br>2522X | | 3.0 | - | - | 426-<br>3004X | 426-<br>3008X | 426-<br>3010X | 426-<br>3012X | 426-<br>3015X | 426-<br>3022X | | 3.5 | - | - | 426-<br>3504X | 426-<br>3508X | 426-<br>3510X | 426-<br>3512X | - | - | | 4.0 | - | - | 426-<br>4004X | 426-<br>4008X | 426-<br>4010X | 426-<br>4012X | - | - | | 5.0 | - | - | 426-<br>5004X | 426-<br>5008X | 426-<br>5010X | 426-<br>5012X | - | - | ## 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 Bantam α product FDA approved under K093139 is the same as the Sleek OTW product in all aspects including material, composition and processing except for the addition of a bridge tubing located in the distal tip of the Sleek OTW product. A list of aspects of the product that are the same is shown below: | Part | Bantam α FDA approved | Sleek | |---------------|-----------------------|-------| | Hub | Same | Same | | Strain relief | Same | Same | | Outer | Same | Same | | Inner | Same | Same | | Balloon | Same | Same | | Marker bands | Same | Same | as supplied in materials table above {5}------------------------------------------------ | Bridge material | NA | Pebax | |-----------------|---------------------------------------------|-------| | Re-inforcement | Same | Same | | | | Same | | Bonds | | Same | | Hub | Glued (inner and outer into hub) | Same | | Proximal bond | Fused (Outer to balloon) | Same | | Marker bands | Crimped (bands to inner) | Same | | Distal bond | Fused (inner to balloon + additional pebax) | Same | Details of the bridging material are laid out below: - · The addition of a bridge material, the same as that used in the LitePAC (K100490) (Sleek - K072947) design. - The distal end configuration of Sleek OTW differs slightly to that of . Bantam a, with a tip lead in profile of: 0.018" for a 1.25mm balloon diameter and 0.021" for a 5.0mm balloon diameter for Sleek OTW; while the tip lead in profile for Bantam α is 0.017" for a 1.25mm balloon and up to 0.020" for a 5.0mm balloon. The only extra testing deemed necessary for Sleek OTW was testing relating to the distal tip due to the bridge tubing addition. All testing of the distal tip passed specification. All testing was done in compliance with ISO 10555-1 and ISO 10555-4 requirements. Due to the minor nature of the change and the fact that all subsequent testing on the Sleek passed requirements the products are deemed substantially equivalent. ## Test Data: The safety and effectiveness of the ClearStream Sleek OTW PTA Catheter has been demonstrated through data collected from non-clinical design verification and design validation tests and analyses. {6}------------------------------------------------ #### Bench Testing The Sleek OTW bench testing validations consist of the same and additional tests as the previous Bartam & validation. All validation work for the Sleek OTW originally around the distal tip change as this was the only difference between the two products, however after a customer request this validation was extended to cover a wider range of tests. The Sleek OTW product is identical to the currently CE marked and FDA approved Bantam a product (K093139) except for the inclusion of a bridge tubing in the distal tip, the distal tip configuration has proven its safety and effectiveness and as such Sleek OTW and Bantam x are deemed to be substantially equivalent despite this addition of the bridge material. As everything up to the tip of the same for the Bantam x and the Sleek OTW, further testing would not have provided any further information. Table 1. lays out the testing performed for the Bantam validation was also referenced as part of the Bantam a project due to the same materials and processes being used) and the corresponding testing done for the Sleek OTW is also described. In addition to the tests carried out in the Bantam x validation, some additional tests were carried out in the Sleek OTW validations described in Table 2 below. These extra validation tests for Sleek OTW were carried out due to a customer request. A full functional validation of Sleek OTW, VP577, was carried out at the customer's request. The tests, "Catheter Body Dimensions" and "Visual and Functional test" from the functional validation of Bantam or, VP494, were not carried out. The catheter body {7}------------------------------------------------ dimension test was not required as the dimensions of the two products are the same up to the distal tip. Visual and functional testing was performed on the line for the Sleek OTW production and so it was not necessary to be performed again as part of the validation. ## Table 1 | Test | Results Bantam α<br>(VP/VR494) & Bantam<br>(VP/VR421,338 & 222) | Results Sleek OTW<br>(VP/VR577) | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Visual and<br>Functional Testing | PASS - VP494<br>[29 of 1.5x20x150],<br>[29 of 5.0x120x150]<br>Also completed on<br>VP421 - Pass<br>(13 of 2.0x220), (13 of 2.5x220)<br>(13 of 5.0x220), (42 of 6.0x220) | N/A | | Catheter Body<br>Diameters | PASS - VP494<br>[29 of 1.5x20x150],<br>[29 of 5.0x120x150]<br>Also completed on<br>VP421 - Pass<br>(13 of 2.0x220), (13 of 2.5x220)<br>(13 of 5.0x220), (29 of 6.0x220) | N/A | | Test | Results Bantam α<br>(VP/VR494) & Bantam | Results Sleek OTW<br>(VP/VR577) | | | (VP/VR421,338 & 222) | | | | PASS - VP494<br>[29 of 5x120mm×150cm]<br>Also completed on<br>VP421 - Pass<br>(13 of 2.5x220) | N/A | | | (13 of 5.0x220) | | | Inflation/Deflation | (29 of 6.0x220)<br>N/A | PASS - VP577 | | Time | | [29 of 5x120mmx150cm] | | Introducer Sheath | PASS | PASS | | Withdrawal | [29 of 5x120mm×150cm] | [29 of 5x120mmx150cm] | | | VP421 - Pass | | | | (13 of 5.0x220), (29 of 6.0x220) | | | Leak and Rated | PASS | *PASS with deviation | | Burst Pressure | [29 of 1.5x20mmx150cm] | [29 of 1.25x15mmx150cm] | | | [29 of 5x120mmx150cm] | [29 of 5x120mmx150cm] | | | VP421 - Pass | | | | (13 of 2.5x220), (13 of 5.0x220) | | | | (29 of 6.0x220) | | | | Results Bantam α | | | Test | (VP/VR494) & Bantam | Results Sleek OTW | | | | (VP/VR577) | | | (VP/VR421,338 & 222) | | | Tensile Test for | VP/VR 338 - Pass | PASS | | Proximal Bond | | | | | (29 of 2x20 Pass) | [29 of 5x120mmx150cm] | | | (29 of 2x120 Pass) | | | | (13 of 5x120 Pass) | | | | (29+13 of 9x60 Pass) | | | Tensile Test for Hub | VP222 - Pass | PASS | | Bond | (29 of 2x60), (29 of 3x60) | [29 of 5x120mmx150cm] | | | (29 of 5x60), (29 of 6x60) | | | | (29 of 8x60), (29 of 9x60) | | | Measurement of the | VP 421 - Pass | PASS | | Working Surface, | (13 2.0x220) | [13 of 1.25x15mmx150cm] | | OD and TL of the | | [13 of 5x120mmx150cm] | | Balloon | | | | Balloon Compliance | VP 421 - Pass | PASS | | Test | (13 2.0x220) | [13 of 1.25x15mmx150cm] | | | (13 6.0x220) | [16 of 5x120mmx150cm] | | Average Burst | VP 421 - Pass | PASS | | Pressure Testing | (13 2.0x220) | [13 of 1.25x15mmx150cm] | | | (13 6.0x220) | [13 of 5x120mmx150cm] | {8}------------------------------------------------ {9}------------------------------------------------ Conclusion: All products had acceptable balloon fatigue performance, noted deviation accepted. The additional tests carried out for Sleek OTW are detailed in Table 2 below: {10}------------------------------------------------ Special 510(k) Submission - ClearStream Technologies Ltd # Table 2 | Test | Results Sleek OTW<br>(VP/VR577) | |------------------------------------|-------------------------------------------------------------| | Profile Measurements of Distal Tip | PASS – VP577<br>[29 of 1.25x15x150],<br>[29 of 5.0x120x150] | | Tensile Test of the Distal Tip | PASS<br>[29 of 1.25x15mmx150cm]<br>[29 of 5x120mmx150cm] | · {11}------------------------------------------------ # Conclusions 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, making the device as safe and effective and therefore market clearance of the Sleek OTW catheter through this 510(k) premarket notification. {12}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ClearStream Technologies Ltd. C/O Fiona Ni Mhullain Regulatory Affairs Manager Moyne Upper Enniscorthy, Ireland DEC 1 2010 Re: K102035 Trade/Device Name: Sleek OTW catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: Undated Received: November 12, 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 (Act (Act that an rot 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 probibitions 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. {13}------------------------------------------------ #### Page 2 - Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loase be advised that 1 Dr. brounder that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 devices and reliable (21 CERC 60) good ation (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 11 you dosho specific ad rios to: your conters offices/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 note 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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address . http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Sincerely yours, Duma R. Valmer \$\hbar\$ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {14}------------------------------------------------ KiUaUDJ page 'q. 1 Special 510(k) Submission - ClearStream Technologies Ltd #### Indications for Use #### 510(k) Number (if known): K102035 Device Name: Sleek OTW PTA Catheter 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 AND/OR (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) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K102035