CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS

{0}------------------------------------------------ K120158 p.1. of 4 ## Coronary Sinus Guide & Lateral Vein Introducer Kits Traditional 510(k | SECTION 5: | 510(k) SUMMARY | |------------|----------------| |------------|----------------| . E. [as required by section 807.92(c)] #### Submitter's Information: A. # AUG 1 4 2012 | Name: | Thomas Medical Products, Inc. | |---------------------------|-------------------------------| | Address: | 65 Great Valley Parkway | | | Malvern, PA 19355 | | Telephone Number: | 610.651.5000 | | Facsimile: | 610.651.5003 | | Contact Person: | Tim Stoudt | | Title: | Regulatory Affairs Manager | | Date Submission Prepared: | January 11, 1012 | #### в. Device Information: Coronary Sinus Guide & Loteral Vein Introducer Kits Trade name: Classification Name(s): Cotheter Introducer (21 CFR §870.1340) Coronary Sinus Guide & Lateral Vein Introducer Kits Common or usual name(s): #### C. Legally marketed device to which equivalence is claimed: - (a) Thomas Medical Products, Inc. SafeSheath Coronary Sinus Guide & Lateral Vein Introducer Kits (k003731) - (b) Merit Medical Systems, Inc. Impress Radiology Catheter (k053171) - (c) Biotronik, Inc. ScoutPro ACS Coronary Sinus Lead Introducer System (k101776) #### D. Description of changes: The reason for this submission is due to improvements made to the SafeSheath Coronary Sinus Guide & Lateral Vein Introducer Kits designed to provide greater protection against environmental factors known to degrade polymers. The specific changes are: | Element of<br>modification | Predicate device<br>k003731 | Modified<br>device | Reason for modification | |----------------------------|-----------------------------|-------------------------------------|-------------------------------------------------------------------------------| | UV Stabilization | None | 0.15 - 0.20%<br>Tinuvin 783<br>w/w | To provide UV stabilization. | | Heat Stabilization | None | 0.08 - 0.12%<br>Irganox 1010<br>w/w | To provide long-term<br>thermal stabilization | | RO tip material | Pebax 4033 w/<br>80% M10 W | Pebax MX-<br>1205 w/80%<br>C5 W | Material optimization to<br>provide greater stability<br>against degradation. | ### Description of the device: The Thomas Medical Products, Inc. (TMP) Coronary Sinus Guide & Lateral Vein Introducer Kits (CSG/LVI) are intended to access the coronary venous system. either alone or in a telescopic assembly with other introducers. The CSG/LVI Introducers serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. CSG/LVI introducers are intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. CSG/LVI introducers come with various curve configurations and lengths to facilitate access to the coronary sinus OS and sub-selective access to angulated lateral vein branches. CSG/LVI introducers are designed as single use devices and for short {1}------------------------------------------------ term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these introducers. The Coronary Sinus Guide Introducer has a peel-away sheath with break-away hemostasis valve. The Lateral Vein Introducer has a break-away hub with integrated handle that requires no cutting and provides a secure grip during slicing, reducing, reducing the risk of lead displacement. The Lateral Vein Introducers have a shaft design with three (3) gradually decreasing stiffness segmentations from proximal to distal. The shaft is reinforced by a metal broid from the proximal end until approximately 0.175 inch from the distal end. The shaft is coated by a medical-grade coating that provides enhanced lubricity when advanced through the Coronary Sinus Guide Introducer. The proximal end of the CSG/LVI Introducers are equipped with a hemostasis valve that reduces the risk of blood loss and air embolism and a side-port with 3-way stopcock to allow fluid infusion and contrast injection. There are differing various versions of the introducer curves that are used according to the anatomy of the present coronary vasculature. The distal soft tip has a tapered outer diometer and the distal tip further contains a polymeric x-roy marker for enhanced visibility under fluoroscopy. Package contents (Coronary Sinus Guide Introducer Kit): - One (1) Coronary Sinus Guide Introducer - One (1) P.T.F.E. coated guidewire - One (1) Curved braided guiding core or non-braided guiding core - One (1) Straight vessel dilator - One (1) Transvalvular Insertion Tool (T.V.I.) - One (1) 18 g XTW needle - One (1) 12 cc syringe Package contents (Lateral Vein Introducer Kit): - One (1) Lateral Vein Introducer - One (1) Transvalvular Insertion Tool (T.V.I.) - One (1) Slicer - One (1) Target Vein Selector Merit Impress Radiology Catheter, k053171 ### Intended use of the device: F. Coronary Sinus Guide & Lateral Vein Introducer Kits are indicated for the introduction of various types of pacing or defibrillator leads and catheters. Thomas Medical Products – A GE Healthcare Company {2}------------------------------------------------ - G. Summary of the technological characteristics of the device compared to the predicate devices: | Features | UV & Heat<br>Stabilized<br>CSG/LVI<br>kits | Non-UV &<br>heat<br>stabilized<br>CSG kits -<br>k003731 | Merit<br>Impress<br>Radiology<br>Catheter<br>k053171 | Biotronik<br>ScoutPro<br>ACS CS<br>Lead<br>Delivery<br>System<br>k101776 | |------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------| | Hemostasis valve provided | Yes | Yes | No | Yes | | Compatible with .038" guide wire | Yes | Yes | Yes | Yes | | Lengths: 40 to 50 cm / 62 cm | Yes | Yes / No | No | Yes | | French sizes: 9 F.I.D. / 7 F.I.D. | Yes | Yes / No | No | No | | Curves: 0 to 180 degree, single<br>or compound curves | Yes | Yes | Yes | Yes | | Peel-away CSG sheath with<br>break-away hemostasis valve | Yes | Yes | No | No | | Wire braid reinforcement<br>completely encapsulated (LVI &<br>Braided Cores) | Yes | No | Yes | Yes | | Radiopaque tip or marker | Yes | No | Yes | Yes | | Side port for infusion and<br>contrast injection | Yes | Yes | No | No | | UV & heat stabilizers . | Yes | No | No | Unk | #### H. Summary of testing: | | Test Description | Results | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | Biocompatibility | | | | | Product applicability: Coronary Sinus Guide & Lateral Vein Introducer components<br>w/ UV and heat stabilization<br>Test Sample: XD-3050-00, Gen. III CSG Sheath, Lot 36564 (proposed device) | | | | USP Pyrogen Study, Material<br>Mediated | Pass, non-pyrogenic | | | Cytotoxicity Study using the<br>ISO elution method | Pass, < grade 2 | | | ISO Maximization<br>Sensitization Study - Extract | Pass, not considered a sensitizer | | | ISO Intracutaneous Study,<br>Extract | Pass, control/test Δ <1.0 | | | ISO Systemic Toxicity Study -<br>Extract | Pass, no mortality or evidence of<br>systemic toxicity | | | ASTM Hemolysis | Pass, hemolytic index = 0.0% | | | Physicochemical testing using<br>an alternative extract -<br>complete | Pass | | | USP Physicochemical Testing<br>- Plastics - Complete | Pass, meets USP limits | {3}------------------------------------------------ | | Test Description | Results | |--|---------------------------------------------------------------------------------------------------|--------------------------------------| | | Biocompatibility (continued) | | | | Product applicability: Lateral Vein Introducer and braided core components | | | | Test Sample: Printed braided Pebax tubing - XD-2186-04 (representative sample of proposed device) | | | | L929 MEM Elution Test | Pass, Grade 0 | | | Kligman Maximization Test - ISO | Pass, Grade 1 | | | Intracutaneous Injection Test - ISO | Pass, considered negligible irritant | | | Systemic Injection Test - ISO | Pass, considered negative | | | Hemolysis - Rabbit Blood - ISO | Pass, 0.0% hemolysis | | | Test Description | Results | |--|-------------------------------------------------------------------------------------------------------------------------------------|---------| | | Simulated Use Testing | | | | Coronary Sinus Guide & Lateral Vein Introducer<br>Test Sample: FCL-156-00 (LVI)/FDL-050-00 (BC)/XD-3050-00 (CSG) - proposed devices | | | | Sheath separation (CSG only) | Pass | | | Hub break force | Pass | | | Test Description | Results | | | Physical/Dimensional Testing | | | | Coronary Sinus Guide & Lateral Vein Introducer<br>Test Sample: FCL-156-00 (LVI) FDL-050-00 (BC)/XD-3050-00 (CSG) - proposed devices | | | | Tip pull test | Pass | | | Tip integrity test | Pass | | | Bend-back testing | Pass | | | Joint interface length (CSG only) | Pass | | | Hub pull force | Pass | | | Tip I.D. | Pass | ### Substantial equivalence rationale: Thomas Medical Products, Inc. considers the Coronary Sinus Guide & Lateral Vein Introducer Kits substantially equivalent to the currently marketed predicate devices. This assessment is based upon analysis of similar technological characteristics, bench testing, and indications for use. Thomas Medical Products - A GE Healthcare Company l. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 AUG 1 4 2012 Thomas Medical Products, Inc. c/o Mr. Timothy Stoudt Regulatory Affairs Manager 65 Great Valley Parkway Malvern, PA 19355 Re: K120158 Trade Name: Coronary Sinus Guide and Lateral Vein Introducer Kits Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: July 30, 2012 Received: July 31, 2012 ### Dear Mr. Stoudt: 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. {5}------------------------------------------------ ## Page 2 - Mr. Timothy Stoudt 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 (OS) 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" (21 CFR 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/Resourcesfor You/Industry/default.htm. Sincerely yours. MZWillian - Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {6}------------------------------------------------ Page of K120158 510(k) Number (if known): Coronary Sinus Guide & Lateral Vein Introducer Kits Device Name: Indications For Use: For the introduction of various types of pacing or defibrillator leads and catheters. Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter-Use (Per 21 CFR 801 Subpart C) (Optional Format 11-13-03) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) M.G. Kelleher (Division Sign-Off) (Division of Cardiovascular Devices K120158 510(k) Number_