(378 days)
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No
The description focuses on the physical components and intended use of a standard electrode catheter, with no mention of AI or ML capabilities.
No.
The device is used for temporary intracardiac stimulation and/or recording potentials during electrophysiologic procedures, which are diagnostic rather than therapeutic.
Yes
The "Intended Use / Indications for Use" states the device is for "intracardiac stimulation and/or recording potentials," which are diagnostic procedures to understand the heart's electrical activity.
No
The device description clearly details a physical catheter with a shaft, tip, and electrodes, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intracardiac stimulation and/or recording potentials" during electrophysiologic procedures. This is a procedure performed within the body (in vivo) to assess the electrical activity of the heart.
- Device Description: The description details a catheter that is inserted into the body through blood vessels and directed into the heart chambers. This is a medical device used for direct interaction with the patient's anatomy.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
This device is clearly designed for use within the body for diagnostic and potentially therapeutic purposes related to the heart's electrical system, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The electrode catheter is intended for temporary use in electrophysiologic procedures for intracardiac stimulation and/or recording potentials.
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Intracardiac
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
OCT 22 1996
Image /page/0/Picture/1 description: The image shows a sequence of characters and numbers written in a bold, handwritten style. The sequence starts with the letter 'K', followed by the numbers '954651'. The characters are all connected, giving the impression of a continuous, flowing script.
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.