← Product Code [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF) · K953750 # CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING (K953750) _Boston Scientific Corp · DRF · Mar 11, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K953750 ## Device Facts - **Applicant:** Boston Scientific Corp - **Product Code:** [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF.md) - **Decision Date:** Mar 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1220 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The electrode catheter is intended for intracardiac electrogram recording and pacing for the purpose of determining conduction times from one cardiac location to another, to localize aberrant conduction pathways and to test for the susceptibility of the cardiac chambers to arrhythmias. ## Device Story Electrode recording catheter used for intracardiac electrogram recording and pacing; percutaneously inserted via femoral or jugular access; directed through vasculature to cardiac chambers. Device features stainless steel braid for torque control, soft atraumatic tip, and up to ten platinum electrodes. Operated by physicians in clinical settings. Provides electrical signals for conduction time determination, pathway localization, and arrhythmia testing. Bench testing confirms mechanical integrity, torque performance, and electrical functionality. Biocompatibility verified per Tripartite/ISO guidelines for short-term intravascular use. ## Clinical Evidence Bench testing only. Evaluated tensile strength of joints (tip electrode/tubing, shaft/tip tubing, connector/shaft), rotational failure, recording/pacing capabilities, and torque performance. Biocompatibility testing performed per Tripartite and ISO guidelines for short-term human intravascular use. No clinical data presented. ## Technological Characteristics Materials: Polyurethane shaft with stainless steel wire braid, platinum electrodes. Dimensions: 6F French size, 100 cm length, 1-10 mm electrode spacing. Energy: Electrical (pacing/recording). Sterilization: Ethylene oxide gas. Design: Soft, non-braided atraumatic tip; various curve styles (Cournand, Josephson, Damato, Multipurpose, Special Procedure, Conduction Study). ## Regulatory Identification An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations. ## Predicate Devices - Elecath's Investigator ([K953750](/device/K953750.md)) - Daig's Response ([K953750](/device/K953750.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K953750/3001 # SUMMARY OF SAFETY AND EFFECTIVENESS Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness. ## A. GENERAL INFORMATION Submitter's Name: Boston Scientific Corporation Address: One Boston Scientific Place Natick, MA 01760-1537 U.S.A Date of Preparation: August 9, 1995 Contact Person: Wanda M. Carpinella Device Generic Name: Electrode Recording Catheter Device Classification: 74DRF Catheter, Electrode Recording MAR 1 1996 ## B. INDICATIONS The electrode catheter is intended for intracardiac electrogram recording and pacing for the purpose of determining conduction times from one cardiac location to another, to localize aberrant conduction pathways and to test for the susceptibility of the cardiac chambers to arrhythmias. ## C. DESCRIPTIVE CHARACTERISTICS The catheters are typically placed percutaneously through femoral or jugular access sites and directed through the vasculature into the cardiac chambers. The catheter is reinforced with a stainless steel braid to enhance torque control and allow easier maneuverability and has a soft tip to reduce the potential for vessel trauma during placement of the catheter. The tip of the catheter is fitted with up to ten platinum electrodes. No new electrode geometries are introduced. Catheters with various curve styles are also available to meet anatomical constraints as well as physician preference and technique. The catheters described in this submission are substantially equivalent to Elecath's Investigator and Daig's Response electrophysiology catheters. Descriptive characteristics between the proposed catheter and the Investigator and Response catheters are compared in Table 1. ## D. PERFORMANCE CHARACTERISTICS The strength of each bond in the catheter was determined. Tensile testing evaluated the strength of the following joints: tip electrode/tubing; shaft/tip tubing and connector/shaft. In addition, the tip electrode was fixed in a chuck and the catheter was rotated until failure occurred. Other testing included an evaluation of recording and pacing capabilities and torque performance testing conducted in bench top models. The testing demonstrated functional integrity and performance characteristics that were substantially equivalent and acceptable for the device's intended use and do not affect safety and effectiveness. Biocompatibility tests conducted according to the Tripartite and ISO Guidelines for Medical Devices demonstrated that materials used in the proposed device are suitable for short-term, human intravascular use. ## E. STERILIZATION, PACKAGING and PYROGENICITY The electrode recording catheters are packaged in an inner Tyvek-lidded blister pack and an outer Tyvek®/mylar pouch. The device is sterilized using ethylene oxide gas. Ethylene oxide gas residuals and bacterial endotoxin levels are monitored for compliance to maximum releasable limits. All testing was performed on sterilized samples and no detrimental effects from the sterilization process were noted ## F. CONCLUSIONS Mechanical, electrical and biological tests verify that the electrode recording catheter meets the essential requirements that are considered necessary for its intended use. 000108 {1} SUMMARY OF SAFETY AND EFFECTIVENESS page 2 of 2 Submitter's Name: Boston Scientific Corporation Address: One Boston Scientific Place Natick, MA 01760-1537 U.S.A Date of Preparation: August 9, 1995 Contact Person: Wanda M. Carpinella Device Generic Name: Electrode Recording Catheter Device Classification: 74DRF Catheter, Electrode Recording | TABLE 1. SUBSTANTIAL EQUIVALENCE COMPARISON CHART | | | | | --- | --- | --- | --- | | CHARACTERISTIC | PROPOSED ELECTRODE CATHETER | ELECATH'S INVESTIGATOR SERIES | DAIG'S RESPONSE SERIES | | Distal Tip Design | Soft, non-braided atraumatic tip | Soft, non-braided atraumatic tip | Soft, non-braided atraumatic tip | | Tip Curve Styles | Cournand Josephson Damato Multipurpose Special Procedure Conduction Study | Cournand Josephson Damato | Cournand Josephson Damato CRD-1 JSN-1 DAO-1 | | Shaft Materials | Polyurethane/Wire Braid Construction | Nylon/Wire Braid Construction | Not Specified | | Electrode Material | Platinum | Platinum | Platinum | | Useable Length | 100 cm | 105 cm | 120 cm 65 cm | | French Size | 6F | 6F | 6F | | Electrode Spacing | 2 to 10 mm | 1 to 5 mm | 2 to 10 mm | | Connector Type | Quick | Quick | Quick Connect | | Tip Electrode Length | 1 mm | 2 mm | Not Specified | | Electrode Number | 2, 4, 6, 8, 10 | 4 | 2, 4, 6, 8, 10 | | Proximal Electrode Length | 1 mm | 2 mm | Not Specified | 000103 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K953750](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K953750) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com