EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER

{0}------------------------------------------------ K110133 Image /page/0/Picture/1 description: The image shows the text "CREGANNA" in large, bold, sans-serif font. Below this, in a smaller font size, is the text "TACTX MEDICAL". The text appears to be slightly distressed or textured, giving it a somewhat vintage or weathered look. JUN 1 0 2011 1353 Dell Avenue Campbell, California 95008, USA Tel: +1 408 364 7100 Fax: +1 408 871 2425 www.cregannatactx.com ## General Information: | Submitter: | Creganna Tactx Medical, Inc. | |-----------------|----------------------------------------------------------------| | | 1353 Dell Avenue | | | Campbell, Ca 95008 | | | Ph: (408) 364-7100 | | | Fax: (408) 871-2425 | | Contact Person: | Dennis Wong | | | Director of Quality | | Date Prepared: | January 17, 2011 | | Device Trade | EMPIRA Rx PTCA Dilatation Catheter and | | name(s): | EMPIRA NC Rx PTCA Dilatation Catheter | | Device Common | PTCA Catheter | | name: | | | Class: | II | | Classification | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | | Name: | (21 CFR 870.5100) | | Product Code: | LOX | ## Predicate Device(s): | Device Name | Reference(s) | |-----------------------------------------------|-----------------| | EMPIRA Rx PTCA Dilatation Catheter | | | Standard PTCA Catheter | 21 CFR 870.5100 | | Cordis Fire Star | P880003 | | Boston Scientific's Maverick2 Monorail | P860019 | | EMPIRA NC Rx PTCA Dilatation Catheter | | | Standard PTCA Catheter | 21 CFR 870.5100 | | Cordis Dura Star | P880003 | | Boston Scientific's Quantum Maverick Monorail | P860019 | Note: Recently, PTCA Catheters were reclassified by the agency from Class II with Special Controls per FDA Guidance Document - Class II Special Controls Guidance Document for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters issued September 8, 2010. ## Intended Use: The EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents. Partners from Idea to Reality Creganna. Registered in Dublin, Ireland: · Reg No 324172 Creganna Medical Devices Inc. Drectors: - In Quinn, Endrac Clarke, Beenard Collers, Helen Ryan, Benard E. Lyons, Daniel G. Tully, George Altien-Daves {1}------------------------------------------------ ## Device Description: The EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters, hereafter referred to as the EMPIRA Catheter, are similar in design. The catheters differ in available configurations (diameter versus balloon working length). The EMPIRA Catheter is a sterile, single-use rapid exchange catheter with a nylon-blend balloon near the distal tip. The distal section of the catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon and the inner lumen permits the use of a guide wire (≤ 0.014 in. / 0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal section of the catheter is a single lumen stainless steel PTFE coated hypotube with a single luer port for the inflation of the balloon. The balloon is designed to provide an inflatable segment of specified diameter and length at recommended pressures. The balloon is folded to achieve a low crossing profile and is connected to a tapered, soft tip. The tapered tip facilitates advancement of the catheter to and through the stenosis. A hydrophilic coating is applied from the distal tip to the guide wire port and over the balloon for increased lubricity. All models have two radiopaque marker bands that aid in the placement of the catheter's balloon segment under fluoroscopy. A balloon protector is placed over the balloon to maintain a low profile and a mandrel is placed in the lumen to maintain patency. The proximal end of the catheter is comprised of a hypotube connected to a plastic hub. The hub can be connected to a standard inflation device and is used to inflate/deflate the balloon. A needle with a luer port is included for flushing the distal lumen prior to the insertion of a guide wire. The EMPIRA Catheter is compatible with standard 0.014" coronary guide wires and 5F guiding catheters. The catheter length is approximately 139 cm. The EMPIRA and EMPIRA NC Rx PTCA Catheters are offered in diameters of 1.5- 4.0 mm and 2.0-4.0, respectively. The working lengths of the treatment balloon are offered in lengths from 6.0 to 30mm. The EMPIRA and EMPIRA NC Rx PTCA Balloon Dilatation Catheter product family consists of multiple sizes. ## Partners from Idea to Reality Creganna. Registered in Dublin, Ireland: Reg No 324177. Creganna Mecical Davires Inc Drectors: Jan Quinn, Enda Quinn, Patrair Collins, Helen Ryan, Banard E. I yoos, Caniel G. Tully, George Atlen-Daves {2}------------------------------------------------ ### Device Comparison: Below is a comparison of the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters with Standard PTCA Catheter as defined by 21 CFR 870.5100: - 1. Like Standard PTCA Catheters, the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters operate on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of the catheter. - 2. Like Standard PTCA Catheters, the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters have a double-lumen coaxial shaft. - 3. Like Standard PTCA Catheters, the balloons on the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters are constructed from a polymer (nylon) and have nominal rated pressures of 8 and 14atm, respectively. - 4. Like Standard PTCA Catheters, the balloon on the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters are available in different diameters and lengths. - 5. Like Standard PTCA Catheters, the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters have radiopaque marker bands to allow for visualization under fluoroscopy. - 6. Like Standard PTCA Catheters, the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters have the same intended use - indicated for the balloon dilatation of stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. In addition, the EMPIRA NC Rx PTCA Balloon Dilatation Catheter is also indicated for the post-delivery expansion of balloon expandable stents. # Partners from Idea to Reality Registered in Dublin, Treland .- Reg No 324172 reganna Medical Devices Inc. Directurs: Jan Quinn, Enda Quan, Padrac Callins, Helen Ryan, Bernard E. Lyons, Daniel G. Tully, George Arken-Davies {3}------------------------------------------------ CREGANNA TACTX MEDICAL | | | | Pre-Dilatation Catheters | | | Post-Dilatation Catheters | | | |-----------------------------|----------------------------|--|--------------------------|--------------------------|-------------------|---------------------------|--------------------------|---------------------------| | | | | EMPIRA | Fire Star | Maverick Monorail | EMPIRA NC | Dura Star | Quantum Maverick Monorail | | Item | | | | | | | | | | Manufacturer | | | Creganna-TACTX Medical | Cordis-Johnson & Johnson | Boston Scientific | Creganna-TACTX Medical | Cordis-Johnson & Johnson | Boston Scientific | | Submission Reference | | | Current Submission | P880003 | P860019 | Current Submission | P880003 | P860019 | | Intended Use | | | Note 1 | Same | Same | Note 1 | Same | Same | | Principle of Operation | | | Note 2 | Same | Same | Note 2 | Same | Same | | Catheter<br>Characteristics | Configuration | | Rapid Exchange | Same | Same | Rapid Exchange | Same | Same | | | Effective Length (cm) | | 139 | 145 | 143 | 139 | 145 | 143 | | Balloon<br>Characteristics | Balloon Lengths (mm) | | 6.0-30mm | 10-30mm | 9.0-30mm | 6.0-30mm | 10-30mm | 8.0-30mm | | | Balloon Diameters (mm) | | 1.5-4.0mm | 1.5-3.5mm | 1.5-4.0mm | 2.0 - 4.0mm | 2.25-4.0mm | 2.0-5.0mm | | | Nominal Pressure (atm) | | 8 | 8 | 6 | 14 | 14 | 12 | | | Rated Burst Pressure (atm) | | 14 | 14 | 12-14 | 20 | 20 | 16-18 | | Other<br>Characteristics | Guidewire compatibility | | ≤0.014in | Same | Same | ≤0.014in | Same | same | | | Sterilization Method | | Ethylene Oxide | Same | Same | Ethylene Oxide | Same | same | | | Single-Use? | | Yes | Same | Same | Same | Same | Same | | | Hydrophilic Coating | | Yes | Yes | Yes | Yes | Yes | Yes | The table below also provides a comparison to other legally marketed devices. Note 1: Indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Also, indicated for post-delivery stent expansion. Note 2: Operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. # Partners from Idea to Reality Creganna. Registered in Oublin, Treland:- Reg No 324172 Creganna Medical Devices Inc. Drectors - Isn Quinn, Enda Quinn, Padrair Collins, Helen Ryan, Benaud E. Lyons, Datiel G. Tully, George Altien-Daves {4}------------------------------------------------ ## Summary of Non-Clinical Testing: The EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters were tested in accordance of FDA Guidance Document - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. The following testing was completed: | Test | Method | Results | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Cytotoxicity | In accordance with ISO 10993 | PASS | | Hemolysis | | | | Platelet and Leukocyte Counts | | | | Partial Thromboplastin Time (PTT) | | | | Complement Activation | | | | Thromboresistance | | | | Bacterial Mutagenicity Test | | | | Intracutaneous Reactivity | | | | Materials Mediated Pyrogen | | | | Sensitization | | | | Acute Systemic Toxicity | | | | USP Physico-chemical | | | | Dimensional Verification | In accordance with applicable | PASS | | Balloon Preparation, Deployment and Retraction | requirements of FDA Guidance<br>Document - Class II Special<br>Controls Guidance Document for<br>Certain Percutaneous Transluminal<br>Coronary Angioplasty (PTCA)<br>Catheters | | | Balloon Rated Burst Pressure | | | | Balloon Fatigue | | | | Balloon Compliance (diameter vs. Pressure) | | | | Balloon Inflation and Deflation Time | | | | Catheter Bond Strength(s) | | | | Tip Pull | | | | Flexibility and Kink | | | | Torque Strength | | | | Radiopacity | | | | Coating Integrity | | | | Particulate Evaluation | | | | Catheter Body Burst Pressure | | | | *Catheter Body Burst Pressure (In-Stent) | | | | *Balloon Rated Burst Pressure (In-Stent) | | | | *Balloon Fatigue (repeat balloon inflations; In-stent) | | | | Packaging Integrity Testing | In accordance with ISO 11607-1<br>and ISO 11607-2 | PASS | | Sterilization | In accordance with ISO 11135-1<br>and ISO 10993-7 | PASS | # Partners from Idea to Reality Creganna. Registerad in Dublin, Ireland: - Reg No 324172 Creganna Medical Devices Inc. Drectors: Jan Quinn, Ende Quinn, Padract Collins, Helmi Ryan, Bernard E. Lyons, Daniel G. Titly, George Airken-Davies {5}------------------------------------------------ | Test | Method | Results | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Shelf Life | In accordance with applicable<br>requirements of FDA Guidance<br>Document - Class II Special<br>Controls Guidance Document for<br>Certain Percutaneous Transluminal<br>Coronary Angioplasty (PTCA)<br>Catheters | PASS | | Animal Study | Comparative testing to currently<br>legally marketed devices in<br>compliance with 21 CFR 58 - GLP | PASS | *This testing is not applicable to the EMPIRA Rx PTCA Dilatation Catheter because it is not intended for use In Stents. ### Conclusion: The EMPIRA and EMPIRA NC Rx PTCA Catheters are substantially equivalent to a Standard PTCA Catheter as defined in 21 CFR 870.5100 and other legally marketed devices with respect to intended use, principle of operation, technological characteristics and safety features. ## Partners from Idea to Reality Creganna. Registered in Dublin, Treland: - Reg No 324172 Creganna Medical Devices Inc. Drectors: - Inn Quinn, Enda Quinn, Patrare Collins, Helen Ryan, Benard !!. I,yons, Damel G. Tolly, George Arken-Daves {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three wing strokes, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUN 1 0 2011 Creganna Tactx Medical, Inc. c/o Mr. Dennis Wong Director of Quality 1353 Dell Avenue Campbell, CA 95008 Re: K110133 EMPIRA™ Rx PTCA Dilatation Catheter Trade/Device Name: EMPIRA™ NC Rx PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 23, 2011 Received: May 24, 2011 Dear Mr. Wong: 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 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 {7}------------------------------------------------ Page 2 – Mr. Dennis Wong 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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 {8}------------------------------------------------ ## 4. Indications for Use Statement 510(k) Number (if known): _ K |(0133 Device Name: _ EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters Indications for Use: "The EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents." Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (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) Page of of | Traditional 510(k) | 23 | |--------------------|------------------------------------| | | (Division Sign-Off) | | | Division of Cardiovascular Devices | | 510(k) Number | K110133 |