INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

{0} OCT.29.1996 10:05AM 4098484533 REGULATORY NO.461 P.2/11 K955122 NOV 4 1996 # 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is: K955122 (To be completed by FDA) # TABLE OF CONTENTS A. GENERAL INFORMATION 2 B. DESCRIPTION OF THE DISEASES AND CONDITIONS FOR WHICH THE MODELS 436-07 AND 437-07 PACING LEADS ARE INDICATED 2 C. DEVICE DESCRIPTION 3 1. Labeling 4 2. Design and Materials 4 3. Performance 6 D. ALTERNATIVES 7 E. POTENTIAL ADVERSE EFFECTS 7 F. SUMMARY OF STUDIES 8 1. Biocompatibility Studies 8 2. Qualification Testing 9 G. CLINICAL SUMMARY 9 H. MANUFACTURING/STERILIZATION 9 I. CONCLUSION 10 1 {1} OCT.29.1996 10:06AM 4098484533 REGULATORY NO.461 P.3/11 510(K) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL PACING LEADS SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION A. GENERAL INFORMATION Device Classification Name: Electrode, Pacemaker, Permanent and Temporary Device Trade Name: - Intermedics Model 436-07 Bipolar Implantable Endocardial Pacing Lead - Intermedics Model 437-07 Unipolar Implantable Endocardial Pacing Lead Applicant's Name and Address: Intermedics Inc. (Establishment Registration Number: 1640319) 4000 Technology Drive Angleton, TX 77515 Primary Company Representative: Alaine Medio, RAC Regulatory Affairs Specialist (409) 848-4528 FAX: (409) 848-4533 Alternate Company Representative: Kathleen M. Chester Senior Regulatory Affairs Specialist (409) 848-4527 FAX: (409) 848-4533 Date of Notification: November 7, 1995 B. DESCRIPTION OF THE DISEASES AND CONDITIONS FOR WHICH THE MODELS 436-07 AND 437-07 PACING LEADS ARE INDICATED The models 436-07 and 437-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus 2 {2} OCT.29.1996 10:06AM 4098484533 REGULATORY NO.461 P.4/11 510(K) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL FACING LEADS SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION ... bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias. In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual chamber pacing system to restore A-V synchrony. ## Contraindications The use of endocardial leads may be contraindicated in the presence of tricuspid atresia, Ebstein's malformation, and various forms of atrial or ventricular transposition, and in patients with mechanical tricuspid heart valves. ## C. Device Description The Intermedics Models 436-07 (bipolar) and 437-07 (unipolar) endocardial pacing leads are designed for use with implantable cardiac pulse generators configured for ventricular applications for long term cardiac pacing. The nominal lead length for the model 436-07 lead is 58 cm and is available in lengths from 40 to 110 cm. The nominal lead length for the model 437-07 lead is also 58 cm and is available in lengths from 40 to 110 cm. The lead connectors are designed to meet VS-1 specifications (an intra-industry agreement standardizing lead-to-pulse generator connection dimensions) for lead connectors. The models 436-07 and 437-07 pacing leads are packaged with the model 367-01 vein lifter and the following stylets: model 367-11 (straight stylet, limber), model 365-12 (straight stylet, firm), model 365-81(tapered stylet, limber), and model 365-82 (tapered stylet, firm). The model 437-07 is also packaged with the following adapters: model 366-29 (Step up adapter, VS-1 unipolar lead to 5 mm unipolar pacer) and model 366-30 (Step up adapter, VS-1 unipolar lead to 6 mm unipolar pacer). The minimum introducer size recommended for both lead models is 10 French. The models 436-07 and 437-07 pacing leads are identical to the Intermedics models 436-02 (K883602, K954719) and 437-02 (K883602, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the ... 3 {3} OCT.29.1996 10:06AM 4098484533 REGULATORY NO.461 P.5/11 510(k) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL PACING LEADS SECTION 2 - 510(k) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719). ## 1. Labeling The generic Intermedics Endocardial Pacing Leads Package insert accompanies each lead. The sterile package labeling for the leads contains the nominal product specification for the particular lead model enclosed. Other than the change in lead model numbers and electrode material; there will be no changes to the labels and/or labeling for these leads. ## 2. Design and Materials ### a. Electrodes The cathode tip electrodes transfer the electrical charge from the pulse generator to the endocardial surface via the pacing lead. This electrical charge stimulates the myocardium, causing cardiac depolarization. The cathode tip of the model 436-07 and 437-07 leads is constructed of IROX-coated titanium and has a blunt shape with three radial cross slots and contact surface area of approximately $8\mathrm{mm}^2$. This electrode is identical to the cathode tip of the commercially available Intermedics Models 430-07 and 431-07. The anode sleeve electrode of the model 436-07 (bipolar), also constructed of IROX-coated titanium, has an approximate surface area of $50\mathrm{mm}^2$ and is 1 inch from the cathode tip. It is identical to the anode sleeve of the commercially available Intermedics Model 430-07. IROX is a metal oxide of iridium and oxygen. IROX belongs to a family of oxides that has an inherently high surface area because of its sub-micron particle size. Other oxides have sub-micron particle size and a high surface area, but the IROX family has additional beneficial properties that yield a more conductive oxide; they are highly corrosion resistant and undergo reversible oxidation-reduction reactions. IROX-coated titanium is currently used in several Intermedics commercially available bradycardia pacing leads. 4 {4} OCT.29.1996 10:07AM 4098484533 REGULATORY NO.461 P.6/11 510(K) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL FACING LEADS SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION b. Lead Body The conductor coils, constructed of three nickel-cobalt alloy wires wound uniaxially (trifilar), transmit electrical activity to and from the heart. Electrical isolation between the connectors and the body environment is provided by a silicone rubber insulation sheath surrounding the conductor coil. The silicone insulation also contributes to the structural strength of the leads. The bipolar lead, model 436-07, consists of an inner coil (joining the connector to the cathode) surrounded by silicone rubber insulation. The second coil (joining the connector to the anode) is wound around the insulation of the first coil. Silicone rubber insulation tubing surrounds this coil and prevents an electrical interface between the body fluids and the coil. The lead body of the model 436-07 is identical in design and material to the commercially available Intermedics Model 436-02. The model 437-07 unipolar lead, consisting of one nickel-cobalt alloy coil surrounded by silicone rubber insulation tubing, is identical in design and material to the commercially available Intermedics Model 437-02. c. Tip Fixation The passive fixation mechanism of the lead tip lodges among the trabeculae in order to prevent dislodgement or movement of the tip electrode from the endocardium. The tip fixation mechanism, made of silicone rubber, is a trailing tines design with radial projections $45^{\circ}$ to the axis of the lead body. This tined lead tip fixation mechanism is identical in design and material to that of the commercially available Intermedics Models 436-02 and 437-02. d. Connector Assembly The connector pin, made of 316L stainless steel, provides the electrical and mechanical connection between the pulse generator and pacing lead. The connector sleeve with O-ring seals is made of silicone 5 {5} OCT.29.1996 10:07AM 4098484533 REGULATORY NO.461 P.7/11 510(K) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL PACING LEADS SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION rubber and provides an insulating seal between the lead and the header of the pulse generator. The connector dimensions are designed to meet the requirements of the VS-1 standard. The connector assembly of the pacing leads is identical in design and material to that of the commercially available Intermedics Models 436-02 and 437-02. ## 3. Performance The Intermedics Models 436-07 and 437-07 pacing leads with IROX-coated titanium electrodes are intended for use with implantable pulse generators. Their performance is expected to demonstrate equivalent clinical performance to commercially available unipolar and bipolar ventricular endocardial pacing leads. ## D. ALTERNATIVES The alternatives to the use of these devices are similar to those described for pulse generators. Surgery or drug therapy have been stated as alternates to cardiac pacing in certain instances. However, when a cardiac pacing system is employed, the side effects of drugs and/or the risks of surgery make these alternatives less desirable. Commercially available pacing leads provide another alternative to the use of the Intermedics Models 436-07 and 437-07 endocardial pacing leads. ## E. POTENTIAL ADVERSE EFFECTS The potential adverse effects associated with the use of the Intermedics Models 438-07 and 435-07 endocardial pacing leads, as well as other pacing leads, may include intermittent or continuous loss of pacing or sensing produced by factors such as displacement of the electrode, unsatisfactory electrode position, breakage of the conductor or its insulation, an increase in thresholds, or poor electrical connection to the pulse generator. When subclavian venipuncture is used for endocardial lead introduction, "extremely medial" insertion of a lead and/or "anatomic abnormalities" may 6 {6} OCT.29.1996 10:07AM 4098484533 REGULATORY NO.461 P.8/11 510(X) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL FACING LEADS SECTION 2 - 510(X) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION contribute to conductor fracture¹,²,³,⁴,⁵. Perforation of the ventricular wall may cause phrenic nerve stimulation. Perforation of the ventricle may also cause diaphragmatic muscle stimulation. Cardiac tamponade has been reported from instances of lead perforation. If the connector is cut off when removing an implanted endocardial lead, the lead's insulation tubing (under sufficient traction) may separate from the lead conductor and slide off, leaving an exposed conductor coil in the heart and vein. As with the introduction of any foreign object into the body, infection can result from the use of endocardial leads. These complications can occur during implantation, explanation, or at any time postoperatively and may require noninvasive or invasive management techniques. ## F. SUMMARY OF STUDIES ### 1. Biocompatibility Studies The models 436-07 and 437-07 pacing leads have been evaluated for biocompatibility in both in vitro and in vivo test systems, and were subjected to the following tests: - Hemolysis Test - MEM Elution Cytology ¹ Stokes K, et al. A possible new complication of subclavian stick: Conductor fracture. *PACE* 1987; 10:748 (Abstract). ² Suzuki Y, Fujimori S, Makoto S, et al. A case of pacemaker lead fracture associated with thoracic outlet syndrome. *PACE* 1988; 11:326. ³ Furman S. Venous cutdown for pacemaker implantation. *Ann Thorac Surg* 1986; 41:438-439. ⁴ Furman S. Subclavian puncture for pacemaker lead placement. *PACE* 1986; 9:467. ⁵ Pyke FE, III. Simultaneous insulation deterioration associated with side-by-side subclavian placement of two polyurethane leads. *PACE* 1988; 11:1571. 7 {7} OCT.29.1996 10:08AM 4098484533 REGULATORY NO.461 P.9/11 510(X) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL FACING LEADS SECTION 2 - 510(X) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION - Ames Mutagenicity - USP Class V - Intramuscular Implantation Test - Maximization Sensitization Test - USP Pyrogen Test Based upon the test data, the materials above were not found to present any toxic liability under physiological conditions. Therefore, the tissue/fluid contacting materials of this pacing system are considered biocompatible. 8 {8} OCT.29.1996 10:08AM 4098484533 REGULATORY NO.461 P.10/11 510(K) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL PACING LEADS SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION --- 2. Qualification Testing Qualification testing was performed on the predicate leads. Since the design of the new leads only incorporates features of the predicate leads (that have already been subjected to qualification testing), no further qualification testing is believed to be necessary. G. CLINICAL SUMMARY The clinical experience of the commercially available Intermedics Models 436-02, 437-02, 430-07, and 431-07 endocardial pacing leads has resulted in an extremely low incidence of clinical complications, demonstrating its effective performance in human implantation. Because of the similarity in design and materials, the models 436-07 and 437-07 pacing leads can be expected to perform with comparable efficacy. H. MANUFACTURING/STERILIZATION Intermedics utilizes environmental controls in the manufacturing facilities which are designed, maintained and closely monitored to achieve an efficacious environment for manufacturing all products. The manufacturing environment is routinely monitored for particle counts, humidity, temperature, and static electricity controls. Additionally, bioburden testing is performed on all products. Vendors of purchased material must be "approved" based upon a quality survey in which Intermedics' field engineers determine whether the vendor has the capability of consistently supplying material that will meet Intermedics' standards. Each quantity of purchased material is assigned a lot number and acceptance or rejection is determined based upon an inspection (conducted on a statistical sampling basis) performed to Intermedics' Engineering specifications. The manufacturing process for the models 436-07 and 437-07 consists of the following assembly processes: connector assembly, molded O-ring assembly, sandblast/coat/mask anode sleeve assembly (model 436-07 only), tip assembly, and final assembly. --- {9} OCT.29.1996 10:08AM 4098484533 REGULATORY NO.461 P.11/11 510(c) NOTIFICATION - MODELS 436-07 AND 437-07 ENDOCARDIAL PACING LEADS SECTION 2 - 510(c) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA AND CERTIFICATION The finished pacing lead and accessories are packaged in the formed pockets of an inner blister tray which is closed by heat sealing a peelable cover around the periphery. This inner blister is then placed into an outer blister which is closed by heat sealing a second peelable cover to it. Cover material is microbial penetration resistant, water resistant, and puncture resistant as suitable for this application. Intermedics sterilization procedures for pacing leads utilize ethylene oxide (EO) sterilizers set for specific parameters derived using methods described in the 1988 AAMI guideline, *Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices*. Upon release from sterilization, pacing lead and accessories are packaged into a carton and the boxed product is inspected prior to being routed to the Finished Goods Inventory area. I. CONCLUSION The information presented in this submission for the Intermedics Models 436-07 (bipolar) and 437-07 (unipolar) pacing leads demonstrates that the intended use of these devices does not differ from that of the commercially available models 436-02, 437-02, 430-07, and 431-07. The clinical experience of the Intermedics endocardial pacing leads has resulted in an extremely low incidence of clinical complications, demonstrating their effective performance in human implantation. Because of the similarity in design and materials, the models 436-07 and 437-07 pacing leads can be expected to perform with comparable efficacy. 10