(214 days)
Not Found
Not Found
No
The summary describes a standard electrode catheter for electrogram recording and pacing, with no mention of AI/ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an electrode catheter intended for intracardiac electrogram recording and pacing to determine conduction times, localize aberrant pathways, and test for arrhythmia susceptibility, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "determining conduction times...to localize aberrant conduction pathways and to test for the susceptibility of the cardiac chambers to arrhythmias," which are diagnostic purposes.
No
The device description clearly describes a physical catheter with electrodes, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that the electrode catheter is placed intracardiac (inside the heart) and is used for intracardiac electrogram recording and pacing. This is a procedure performed within the body, not on specimens taken from the body.
The device is an invasive medical device used for diagnostic and therapeutic procedures within the heart.
N/A
Intended Use / 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 susceptability of the cardiac chambers to arrhythmias.
Product codes
74DRF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac chambers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Tripatite and ISO Guidelines for Medical Devices demonstrated that materials used in the proposed device are suitable for short-term, human intravascular use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K955750/5001
MAR I I 1996
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 |
INDICATIONS
в.
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 susceptability 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.
PERFORMANCE CHARACTERISTICS D.
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 Tripatite and ISO Guidelines for Medical Devices demonstrated that materials used in the proposed device are suitable for short-term, human intravascular use.
STERILIZATION, PACKAGING and PYROGENICITY E.
The electrode recording catheters are packaged in an innerTyvek-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
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
SUMMARY OF SAFETY AND EFFECTIVENESS
CONMARY OF SAFETY Page 2 of 2 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 |
Image /page/1/Picture/3 description: The image shows a black blob on a white background. The blob is irregularly shaped and appears to be a solid mass. The contrast between the black blob and the white background is stark, making the blob stand out prominently. The image is simple and lacks any additional details or features.