(378 days)
The electrode catheter is intended for temporary use in electrophysiologic procedures for intracardiac stimulation and/or recording potentials.
The catheters are typically placed percutaneously through femoral or jugular access sites and directed through the vasculature into the cardiac chambers. The catheter is composed of a wirereinforced, polyurethane shaft and a soft, distal tip. The distal end of the catheter is fitted with three ring electrodes and one tip electrode. No new electrode geometries are introduced. Catheters with various tip lengths are available to meet anatomical constraints as well as physician preference and technique.
The provided text is a summary of safety and effectiveness for an Electrode Recording Catheter, submitted by Boston Scientific Corporation in 1996. It describes the device, its intended use, and general performance characteristics. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving the device meets them, or details about ground truth, expert involvement, and sample sizes.
The document states:
- "The results 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."
- "Mechanical, electrical and biological tests verify that the electrode recording catheter meets the essential requirements that are considered necessary for its intended use."
These statements indicate that tests were performed and deemed acceptable, but the specific acceptance criteria, detailed study methodology, and quantitative results are not provided.
Therefore, I cannot populate the requested tables and sections with the information present in the input text. The input focuses on regulatory submission details and general safety/effectiveness claims, rather than a detailed performance study with specific metrics and methodologies.
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OCT 22 1996
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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: | October 6, 1995 | |
| Contact Person: | Wanda M. Carpinella | |
| Device Generic Name: | Electrode Recording Catheter | |
| Device Classification: | 74DRF Catheter, Electrode Recording |
B. INDICATIONS
The electrode catheter is intended for temporary use in electrophysiologic procedures for intracardiac stimulation and/or recording potentials.
DESCRIPTIVE CHARACTERISTICS C.
The catheters are typically placed percutaneously through femoral or jugular access sites and directed through the vasculature into the cardiac chambers. The catheter is composed of a wirereinforced, polyurethane shaft and a soft, distal tip. The distal end of the catheter is fitted with three ring electrodes and one tip electrode. No new electrode geometries are introduced. Catheters with various tip lengths are available to meet anatomical constraints as well as physician preference and technique.
Substantial equivalence for the proposed catheter is based on similarities in design, materials and dimensions to Boston Scientific's currently-marketed Polaris catheter and Medironic's CardioRhythm Voyagr catheter.
D. PERFORMANCE CHARACTERISTICS
The structural strength of each bond in the catheter was determined. The results 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 demonstrated that materials used in the proposed device are suitable for short-term, human intravascular use.
E. STERILIZATION. PACKAGING and PYROGENICITY
The electrode recording catheter is 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 were shown to be less than the acceptable maximums. All testing was performed on sterilized samples and no detrimental effects from the sterilization process were noted.
CONCLUSIONS F.
Mechanical, electrical and biological tests verify that the electrode recording catheter meets the essential requirements that are considered necessary for its intended use.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
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.(b)
Classification. Class II (performance standards).